Trial Outcomes & Findings for A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (NCT NCT02541383)

Last Updated: 2025-04-13

Results Overview

Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT. According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1085 participants

Primary outcome timeframe

At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT

Results posted on

2025-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	VTd Only All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.	DVTd Only * Arm/Group Title: Characters Remaining: 91 All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.	VTd-OBS All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation	VTd-DARA All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy	DVTd-OBS All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation.	DVTd-DARA All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy.
Overall Study STARTED	114	85	215	213	229	229
Overall Study COMPLETED	53	38	165	170	205	204
Overall Study NOT COMPLETED	61	47	50	43	24	25

Reasons for withdrawal

Reasons for withdrawal
Measure	VTd Only All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.	DVTd Only * Arm/Group Title: Characters Remaining: 91 All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), not re-randomized in maintenance phase.	VTd-OBS All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation	VTd-DARA All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy	DVTd-OBS All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to observation.	DVTd-DARA All patients randomized to the DVTd group (Daratumumab, Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (even those who didn't receive any study treatment), re-randomized to daratumumab monotherapy.
Overall Study Death	50	37	48	41	21	25
Overall Study Lost to Follow-up	5	3	1	1	3	0
Overall Study Consent withdrawn	5	6	1	1	0	0
Overall Study Sponsor's decision	1	1	0	0	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VTd Only n=114 Participants Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), not re-randomized in maintenance phase	DVTd Only n=85 Participants Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), not re-randomized in maintenance phase	VTd-OBS n=215 Participants Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to observation	VTd-DARA n=213 Participants Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to daratumumab monotherapy	DVTd-OBS n=229 Participants Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to observation	DVTd-DARA n=229 Participants Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to daratumumab monotherapy	Total n=1085 Participants Total of all reporting groups
Age, Continuous	57.7 years STANDARD_DEVIATION 6.36 • n=114 Participants	57.8 years STANDARD_DEVIATION 7.5 • n=85 Participants	56 years STANDARD_DEVIATION 6.96 • n=215 Participants	56.3 years STANDARD_DEVIATION 7.38 • n=213 Participants	56.8 years STANDARD_DEVIATION 6.83 • n=229 Participants	56.4 years STANDARD_DEVIATION 6.79 • n=229 Participants	56.6 years STANDARD_DEVIATION 6.98 • n=1085 Participants
Sex: Female, Male Female	42 Participants n=114 Participants	37 Participants n=85 Participants	94 Participants n=215 Participants	87 Participants n=213 Participants	96 Participants n=229 Participants	94 Participants n=229 Participants	450 Participants n=1085 Participants
Sex: Female, Male Male	72 Participants n=114 Participants	48 Participants n=85 Participants	121 Participants n=215 Participants	126 Participants n=213 Participants	133 Participants n=229 Participants	135 Participants n=229 Participants	635 Participants n=1085 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment BELGIUM	15 participants n=114 Participants	5 participants n=85 Participants	11 participants n=215 Participants	18 participants n=213 Participants	23 participants n=229 Participants	17 participants n=229 Participants	89 participants n=1085 Participants
Region of Enrollment FRANCE	70 participants n=114 Participants	64 participants n=85 Participants	191 participants n=215 Participants	169 participants n=213 Participants	177 participants n=229 Participants	183 participants n=229 Participants	854 participants n=1085 Participants
Region of Enrollment NETHERLANDS	29 participants n=114 Participants	16 participants n=85 Participants	13 participants n=215 Participants	26 participants n=213 Participants	29 participants n=229 Participants	29 participants n=229 Participants	142 participants n=1085 Participants
Baseline ISS Stage I	47 participants n=114 Participants	25 participants n=85 Participants	88 participants n=215 Participants	93 participants n=213 Participants	83 participants n=229 Participants	96 participants n=229 Participants	432 participants n=1085 Participants
Baseline ISS Stage II	52 participants n=114 Participants	41 participants n=85 Participants	96 participants n=215 Participants	85 participants n=213 Participants	118 participants n=229 Participants	96 participants n=229 Participants	488 participants n=1085 Participants
Baseline ISS Stage III	15 participants n=114 Participants	19 participants n=85 Participants	31 participants n=215 Participants	35 participants n=213 Participants	28 participants n=229 Participants	37 participants n=229 Participants	165 participants n=1085 Participants
Baseline Type of Myeloma Biclonal	1 participants n=114 Participants	2 participants n=85 Participants	10 participants n=215 Participants	8 participants n=213 Participants	5 participants n=229 Participants	5 participants n=229 Participants	31 participants n=1085 Participants
Baseline Type of Myeloma IgA	15 participants n=114 Participants	14 participants n=85 Participants	46 participants n=215 Participants	43 participants n=213 Participants	36 participants n=229 Participants	37 participants n=229 Participants	191 participants n=1085 Participants
Baseline Type of Myeloma IgD	3 participants n=114 Participants	1 participants n=85 Participants	3 participants n=215 Participants	7 participants n=213 Participants	2 participants n=229 Participants	2 participants n=229 Participants	18 participants n=1085 Participants
Baseline Type of Myeloma IgG	79 participants n=114 Participants	54 participants n=85 Participants	126 participants n=215 Participants	128 participants n=213 Participants	159 participants n=229 Participants	138 participants n=229 Participants	684 participants n=1085 Participants
Baseline Type of Myeloma IgM	0 participants n=114 Participants	0 participants n=85 Participants	1 participants n=215 Participants	1 participants n=213 Participants	0 participants n=229 Participants	1 participants n=229 Participants	3 participants n=1085 Participants
Baseline Type of Myeloma Kappa	11 participants n=114 Participants	9 participants n=85 Participants	17 participants n=215 Participants	18 participants n=213 Participants	17 participants n=229 Participants	27 participants n=229 Participants	99 participants n=1085 Participants
Baseline Type of Myeloma Lambda	3 participants n=114 Participants	5 participants n=85 Participants	10 participants n=215 Participants	7 participants n=213 Participants	8 participants n=229 Participants	17 participants n=229 Participants	50 participants n=1085 Participants
Baseline Type of Myeloma Negative immunofixation	2 participants n=114 Participants	0 participants n=85 Participants	2 participants n=215 Participants	1 participants n=213 Participants	2 participants n=229 Participants	2 participants n=229 Participants	9 participants n=1085 Participants
Time since initial diagnosis to randomization (months)	1.6 months STANDARD_DEVIATION 2.65 • n=114 Participants	1.3 months STANDARD_DEVIATION 0.96 • n=85 Participants	1.2 months STANDARD_DEVIATION 0.86 • n=215 Participants	1.2 months STANDARD_DEVIATION 0.87 • n=213 Participants	1.2 months STANDARD_DEVIATION 1.08 • n=229 Participants	1.2 months STANDARD_DEVIATION 0.95 • n=229 Participants	1.2 months STANDARD_DEVIATION 1.25 • n=1085 Participants
Presence of diffuse myeloma-related osteopenia No	100 participants n=114 Participants	76 participants n=85 Participants	197 participants n=215 Participants	194 participants n=213 Participants	203 participants n=229 Participants	208 participants n=229 Participants	978 participants n=1085 Participants
Presence of diffuse myeloma-related osteopenia Yes	14 participants n=114 Participants	9 participants n=85 Participants	18 participants n=215 Participants	17 participants n=213 Participants	25 participants n=229 Participants	19 participants n=229 Participants	102 participants n=1085 Participants
Presence of diffuse myeloma-related osteopenia Missing	0 participants n=114 Participants	0 participants n=85 Participants	0 participants n=215 Participants	2 participants n=213 Participants	1 participants n=229 Participants	2 participants n=229 Participants	5 participants n=1085 Participants
Presence of evaluable bone marrow assessment No	3 participants n=114 Participants	0 participants n=85 Participants	3 participants n=215 Participants	3 participants n=213 Participants	4 participants n=229 Participants	6 participants n=229 Participants	19 participants n=1085 Participants
Presence of evaluable bone marrow assessment Yes	111 participants n=114 Participants	85 participants n=85 Participants	212 participants n=215 Participants	210 participants n=213 Participants	225 participants n=229 Participants	223 participants n=229 Participants	1066 participants n=1085 Participants
Bone marrow cellularity Hypercellular	30 participants n=114 Participants	28 participants n=85 Participants	62 participants n=215 Participants	63 participants n=213 Participants	62 participants n=229 Participants	46 participants n=229 Participants	291 participants n=1085 Participants
Bone marrow cellularity Indeterminate	1 participants n=114 Participants	3 participants n=85 Participants	8 participants n=215 Participants	8 participants n=213 Participants	6 participants n=229 Participants	8 participants n=229 Participants	34 participants n=1085 Participants
Bone marrow cellularity Moderately cellular	24 participants n=114 Participants	19 participants n=85 Participants	50 participants n=215 Participants	42 participants n=213 Participants	41 participants n=229 Participants	47 participants n=229 Participants	223 participants n=1085 Participants
Bone marrow cellularity Normocellular	52 participants n=114 Participants	31 participants n=85 Participants	78 participants n=215 Participants	93 participants n=213 Participants	101 participants n=229 Participants	112 participants n=229 Participants	467 participants n=1085 Participants
Bone marrow cellularity Severely acellular	5 participants n=114 Participants	3 participants n=85 Participants	13 participants n=215 Participants	5 participants n=213 Participants	14 participants n=229 Participants	10 participants n=229 Participants	50 participants n=1085 Participants
Bone marrow cellularity Missing	2 participants n=114 Participants	1 participants n=85 Participants	4 participants n=215 Participants	2 participants n=213 Participants	5 participants n=229 Participants	6 participants n=229 Participants	20 participants n=1085 Participants

PRIMARY outcome

Timeframe: At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT

Population: All participants randomized in the first randomization.

Outcome measures

Outcome measures
Measure	Arm A Part 1 n=542 Participants Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD): Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation	Arm B Part 1 n=543 Participants Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab: Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
Post-Consolidation Stringent Complete Response (sCR) Rate	110 Participants	157 Participants

PRIMARY outcome

Timeframe: From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date).

Population: All participants randomized in the second randomization even if they did not receive any study treatment dose.

Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the completion of Maintenance therapy.

Outcome measures

Outcome measures
Measure	Arm A Part 1 n=444 Participants Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD): Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation	Arm B Part 1 n=442 Participants Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab: Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
Progression Free Survival (PFS) Post Completion of Maintenance Therapy	46.7 Months Interval 40.0 to The upper limit of the Confidence Interval is not estimable due to insufficient number of participants with events.	NA Months The Median time to progression was not reached in this arm. Consequently, the lower and upper limit of the Confidence Interval is not available due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study

Population: All participants randomized in the first randomization even if they did not receive any study treatment dose.

Progression Free Survival (PFS) is defined as the duration from the date of first randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the end of the study

Outcome measures

Outcome measures
Measure	Arm A Part 1 n=542 Participants Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD): Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation	Arm B Part 1 n=543 Participants Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab: Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
Progression Free Survival (PFS) From First Randomization up to the End of the Study	52.8 Months Interval 47.5 to 58.7	83.7 Months Interval 70.2 to The upper limit of the Confidence Interval is not estimable due to insufficient number of participants with events.

Adverse Events

VTd - Part 1

Serious events: 261 serious events

Other events: 529 other events

Deaths: 139 deaths

DVTd - Part 1

Serious events: 264 serious events

Other events: 534 other events

Deaths: 83 deaths

VTd-OBS - Part 2

Serious events: 35 serious events

Other events: 170 other events

Deaths: 48 deaths

VTd-DARA - Part 2

Serious events: 58 serious events

Other events: 194 other events

Deaths: 41 deaths

DVTd-OBS - Part 2

Serious events: 50 serious events

Other events: 198 other events

Deaths: 21 deaths

DVTd-DARA - Part 2

Serious events: 43 serious events

Other events: 205 other events

Deaths: 25 deaths

Serious adverse events

Serious adverse events
Measure	VTd - Part 1 n=538 participants at risk 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. It includes deaths that occurred from the 1st randomization to the end of the study. For the all-cause mortality report, the at risk population also includes the patients randomized but who didn't receive any treatment.	DVTd - Part 1 n=536 participants at risk 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. It includes deaths that occurred from the 1st randomization to the end of the study. For the all-cause mortality report, the at risk population also includes the patients randomized but who didn't receive any treatment.	VTd-OBS - Part 2 n=215 participants at risk All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to observation group (OBS) at rando 2. It includes deaths that occurred from the 2nd randomization to the end of the study. That means that all deaths reported in this arm are also reported in the arm VTd - Part 1.	VTd-DARA - Part 2 n=211 participants at risk All patients randomized to the VTd group (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. It includes deaths that occurred from the 2nd randomization to the end of the study. That means that all deaths reported in this arm are also reported in the arm VTd - Part 1.	DVTd-OBS - Part 2 n=229 participants at risk All 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. It includes deaths that occurred from the 2nd randomization to the end of the study. That means that all deaths reported in this arm are also reported in the arm DVTd - Part 1.	DVTd-DARA - Part 2 n=229 participants at risk 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. It includes deaths that occurred from the 2nd randomization to the end of the study. That means that all deaths reported in this arm are also reported in the arm DVTd - Part 1.
Blood and lymphatic system disorders Agranulocytosis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Anaemia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Eosinophilia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Febrile Bone Marrow Aplasia	2.2% 12/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 7/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Febrile Neutropenia	3.0% 16/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.2% 12/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Haemolytic Uraemic Syndrome	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Histiocytosis Haematophagic	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Leukopenia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Lymphopenia	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 7/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Neutropenia	1.5% 8/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.1% 22/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Thrombocytopenia	0.74% 4/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.2% 12/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Thrombotic Microangiopathy	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Acute Coronary Syndrome	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Angina Pectoris	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Arrhythmia Supraventricular	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Atrial Fibrillation	1.1% 6/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Atrial Flutter	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Atrial Tachycardia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Atrioventricular Block	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Bradycardia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Cardiac Amyloidosis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Cardiac Arrest	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Cardiac Failure	0.93% 5/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Cardiac Failure Acute	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Coronary Artery Disease	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Mucosal Inflammation	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Non-Cardiac Chest Pain	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Oedema Peripheral	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Pain	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Pyrexia	4.1% 22/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.8% 15/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Sudden Death	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Hepatobiliary disorders Cholecystitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Hepatobiliary disorders Cholelithiasis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Hepatobiliary disorders Hepatic Failure	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Hepatobiliary disorders Hepatocellular Injury	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Hepatobiliary disorders Hepatomegaly	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Immune system disorders Anaphylactic Shock	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Immune system disorders Hypersensitivity	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Immune system disorders Sarcoidosis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Anal Abscess	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Appendicitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Arthritis Bacterial	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Bacterial Pyelonephritis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Bacterial Sepsis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Bartholinitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Bronchiolitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Bronchitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 7/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Bronchopulmonary Aspergillosis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Cellulitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Cellulitis Staphylococcal	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Chronic Sinusitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Clostridial Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Clostridium Colitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Clostridium Difficile Colitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Clostridium Difficile Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Cystitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Cytomegalovirus Gastroenteritis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Cytomegalovirus Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Cytomegalovirus Oesophagitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Dermo-Hypodermitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Device Related Sepsis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Diverticulitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Ear Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Eczema Infected	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Encephalitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Endocarditis Staphylococcal	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Enterococcal Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Escherichia Sepsis	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Epstein-Barr Virus Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Erysipelas	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Escherichia Bacteraemia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Fungal Oesophagitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Gastroenteritis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Gastroenteritis Salmonella	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Gastroenteritis Viral	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Hepatitis E	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Herpes Zoster	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Herpes Zoster Meningitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Infectious Colitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Infective Thrombosis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Influenza	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.75% 4/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Intervertebral Discitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Localised Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Intestinal Sepsis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Legionella Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Lower Respiratory Tract Infection Viral	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Lung Infection	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 5/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.4% 3/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.4% 3/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 3/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Meningitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Metapneumovirus Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Parotitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Peritonitis	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumococcal Sepsis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumocystis Jirovecii Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumocystis Jirovecii Pneumonia	0.74% 4/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia	1.7% 9/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.9% 21/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.1% 7/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Acinetobacter	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Bacterial	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Escherichia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Fungal	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Haemophilus	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Influenzal	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Legionella	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Parainfluenzae Viral	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Pneumococcal	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Pseudomonal	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Respiratory Syncytial Viral	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia Viral	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pulmonary Sepsis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pyelonephritis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Respiratory Syncytial Virus Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Respiratory Tract Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Respiratory Tract Infection Viral	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Rhinitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Salmonella Sepsis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Sepsis	2.0% 11/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 7/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Septic Shock	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.75% 4/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Sinusitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Skin Bacterial Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Spinal Cord Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Staphylococcal Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Staphylococcal Sepsis	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Streptococcal Bacteraemia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Streptococcal Endocarditis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Streptococcal Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Streptococcal Sepsis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Subcutaneous Abscess	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Systemic Mycosis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Thrombophlebitis Septic	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Upper Respiratory Tract Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Urinary Tract Infection	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Urosepsis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Varicella	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Varicella Zoster Virus Infection	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Viral Diarrhoea	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Viral Infection	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Viral Rhinitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Blood Stem Cell Harvest Failure	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Burns Second Degree	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Femur Fracture	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Forearm Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Fractured Sacrum	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Hand Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Humerus Fracture	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Coronary Artery Stenosis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Mitral Valve Prolapse	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Myocardial Infarction	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Myocardial Ischaemia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Myocarditis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Paroxysmal Arrhythmia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Pericardial Effusion	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Pericarditis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Sinus Tachycardia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Supraventricular Tachycardia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Tachycardia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Cardiac disorders Ventricular Fibrillation	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Congenital, familial and genetic disorders Fanconi Syndrome	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Ear and labyrinth disorders Vertigo	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Endocrine disorders Hyperparathyroidism	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Eye disorders Blepharitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Eye disorders Cataract	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Eye disorders Retinal Detachment	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Eye disorders Uveitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Eye disorders Vision Blurred	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Abdominal Pain	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Abdominal Pain Upper	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Anal Fistula	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Colitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Colitis Ischaemic	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Constipation	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Diarrhoea	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Diverticular Perforation	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Diverticulum Intestinal Haemorrhagic	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Duodenal Obstruction	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Dysphagia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Faecaloma	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Hernial Eventration	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Inflammatory Bowel Disease	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Intestinal Obstruction	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Large Intestine Perforation	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Mallory-Weiss Syndrome	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Nausea	1.1% 6/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.1% 6/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Neutropenic Colitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Pancreatic Cyst	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Pancreatitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Proctitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Stomatitis	0.93% 5/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.75% 4/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Umbilical Hernia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Vomiting	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.1% 6/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Asthenia	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Chest Discomfort	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Chest Pain	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Chills	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Death	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders General Physical Health Deterioration	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.1% 6/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Hernia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Hyperthermia	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Inflammation	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Influenza Like Illness	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Malaise	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Medical Device Site Joint Pain	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Peripheral Sensory Neuropathy	3.0% 16/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.1% 11/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Polyneuropathy	0.74% 4/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Posterior Reversible Encephalopathy Syndrome	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Sciatica	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Seizure	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Spinal Cord Compression	0.93% 5/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Status Epilepticus	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Syncope	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Transient Global Amnesia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Transient Ischaemic Attack	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Product Issues Device Breakage	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Abnormal Behaviour	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Agitation	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Anxiety	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Anxiety Disorder	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Confusional State	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Delusional Disorder, Unspecified Type	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Depression	0.74% 4/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Major Depression	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Mental Disorder	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Suicide Attempt	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Renal and urinary disorders Acute Kidney Injury	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Renal and urinary disorders Chronic Kidney Disease	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Renal and urinary disorders Cystitis Haemorrhagic	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Renal and urinary disorders Myeloma Cast Nephropathy	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Renal and urinary disorders Renal Colic	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Renal and urinary disorders Renal Failure	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Renal and urinary disorders Renal Impairment	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Renal and urinary disorders Renal Tubular Necrosis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Renal and urinary disorders Urinary Bladder Haemorrhage	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Reproductive system and breast disorders Endometrial Hyperplasia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Reproductive system and breast disorders Genital Prolapse	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Reproductive system and breast disorders Prostatitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Reproductive system and breast disorders Uterine Cervical Metaplasia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Asthma	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.74% 4/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Eosinophilic Pneumonia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Idiopathic Interstitial Pneumonia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Lung Disorder	1.1% 6/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 10/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Pharyngeal Oedema	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 5/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	3.7% 20/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.5% 8/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Sinus Polyp	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Acute Generalised Exanthematous Pustulosis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Blister	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Drug Reaction with Eosinophilia and Systemic Symptoms	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Rash	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Toxic Skin Eruption	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Urticaria	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Arteritis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Deep Vein Thrombosis	1.3% 7/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Hypertension	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Hypotension	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Orthostatic Hypotension	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Peripheral Artery Thrombosis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Peripheral Ischaemia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Phlebitis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Thrombophlebitis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Vena Cava Thrombosis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Venous Thrombosis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Jaw Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Overdose	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Pelvic Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Perirenal Haematoma	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Post Procedural Complication	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Product Preparation Error	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.93% 5/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Spinal Fracture	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Toxicity to Various Agents	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Upper Limb Fracture	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Investigations Blood Creatinine Increased	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Investigations General Physical Condition Abnormal	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Investigations Hepatic Enzyme Abnormal	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Cell Death	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Decreased Appetite	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Dehydration	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.75% 4/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Diabetes Mellitus	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Diabetic Metabolic Decompensation	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Electrolyte Imbalance	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Fluid Overload	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Fluid Retention	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Gout	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Hyperglycaemia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Tumour Lysis Syndrome	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Back Pain	1.7% 9/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 9/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Bone Pain	0.74% 4/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.56% 3/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Gouty Arthritis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Intervertebral Disc Compression	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Osteonecrosis of Jaw	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Spinal Pain	0.56% 3/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic Thyroid Cancer	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Recurrent	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Blastic Plasmacytoid Dendritic Cell Neoplasia	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's Disease	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Tract Adenoma	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal Proliferative Breast Lesion	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip Squamous Cell Carcinoma	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Natural Killer-Cell Lymphoblastic Lymphoma	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Tumour Benign	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Oncocytoma	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Skin	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-Cell Lymphoma	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Acute Motor-Sensory Axonal Neuropathy	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Amnestic Disorder	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Autonomic Neuropathy	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Cerebellar Haematoma	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Cerebral Haemorrhage	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Cerebrovascular Accident	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Cervicobrachial Syndrome	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Encephalopathy	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Epidural Lipomatosis	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Headache	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Hemiparaesthesia	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Hemiparesis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Ischaemic Stroke	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Neuralgia	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Neuropathy Peripheral	0.19% 1/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Paraesthesia	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Paraparesis	0.00% 0/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.19% 1/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Peripheral Motor Neuropathy	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Peripheral Sensorimotor Neuropathy	0.37% 2/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.37% 2/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.

Other adverse events

Other adverse events
Measure	VTd - Part 1 n=538 participants at risk 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. It includes deaths that occurred from the 1st randomization to the end of the study. For the all-cause mortality report, the at risk population also includes the patients randomized but who didn't receive any treatment.	DVTd - Part 1 n=536 participants at risk 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. It includes deaths that occurred from the 1st randomization to the end of the study. For the all-cause mortality report, the at risk population also includes the patients randomized but who didn't receive any treatment.	VTd-OBS - Part 2 n=215 participants at risk All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to observation group (OBS) at rando 2. It includes deaths that occurred from the 2nd randomization to the end of the study. That means that all deaths reported in this arm are also reported in the arm VTd - Part 1.	VTd-DARA - Part 2 n=211 participants at risk All patients randomized to the VTd group (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. It includes deaths that occurred from the 2nd randomization to the end of the study. That means that all deaths reported in this arm are also reported in the arm VTd - Part 1.	DVTd-OBS - Part 2 n=229 participants at risk All 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. It includes deaths that occurred from the 2nd randomization to the end of the study. That means that all deaths reported in this arm are also reported in the arm DVTd - Part 1.	DVTd-DARA - Part 2 n=229 participants at risk 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. It includes deaths that occurred from the 2nd randomization to the end of the study. That means that all deaths reported in this arm are also reported in the arm DVTd - Part 1.
Blood and lymphatic system disorders Anaemia	14.5% 78/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	13.8% 74/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.3% 7/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.8% 8/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Febrile Neutropenia	2.4% 13/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.0% 27/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Leukopenia	3.0% 16/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.6% 30/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Lymphopenia	12.1% 65/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	19.8% 106/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.3% 5/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.6% 14/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.2% 12/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.3% 19/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Neutropenia	15.4% 83/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	27.8% 149/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.8% 6/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.3% 7/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.2% 5/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Blood and lymphatic system disorders Thrombocytopenia	13.4% 72/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	20.3% 109/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.3% 7/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.4% 10/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Ear and labyrinth disorders Vertigo	8.0% 43/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.5% 40/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.8% 6/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.4% 5/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.2% 5/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.6% 6/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Eye disorders Vision Blurred	5.8% 31/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.3% 23/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Abdominal Pain	4.1% 22/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.7% 36/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.3% 7/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.1% 7/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Abdominal Pain Upper	5.2% 28/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.8% 31/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.3% 5/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.4% 5/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.2% 5/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.5% 8/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Constipation	47.4% 255/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	50.6% 271/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.7% 10/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.6% 6/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.1% 7/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Diarrhoea	17.1% 92/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	19.6% 105/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.7% 10/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	15.6% 33/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.0% 16/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	10.9% 25/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Dry Mouth	3.7% 20/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.0% 27/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Nausea	24.0% 129/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	29.7% 159/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	15.6% 33/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.4% 10/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Stomatitis	19.0% 102/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	17.4% 93/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Gastrointestinal disorders Vomiting	9.3% 50/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	15.5% 83/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	14.7% 31/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 3/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.5% 8/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Asthenia	29.6% 159/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	32.8% 176/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	12.6% 27/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	16.6% 35/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.4% 26/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.4% 26/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Chills	4.1% 22/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.8% 47/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.8% 8/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Fatigue	15.8% 85/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	14.0% 75/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.2% 9/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.6% 14/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.4% 17/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.0% 16/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Influenza Like Illness	5.6% 30/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.3% 34/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.3% 20/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	10.0% 21/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	12.7% 29/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	14.0% 32/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Injection Site Erythema	5.2% 28/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.8% 31/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Malaise	4.6% 25/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.5% 35/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.8% 6/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 3/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Oedema Peripheral	28.6% 154/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	31.0% 166/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.7% 8/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.3% 9/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.9% 9/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.7% 13/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
General disorders Pyrexia	19.3% 104/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	24.8% 133/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.3% 7/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.5% 20/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.4% 17/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.9% 18/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Immune system disorders Hypogammaglobulinaemia	5.4% 29/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.0% 48/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.3% 7/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	14.2% 30/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.9% 9/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	13.1% 30/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Bronchitis	14.7% 79/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	20.0% 107/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	33.0% 71/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	36.5% 77/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	27.5% 63/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	40.6% 93/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Gastroenteritis	0.93% 5/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.8% 15/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.0% 13/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.6% 16/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.0% 16/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.6% 22/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Herpes Zoster	3.9% 21/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.0% 27/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	12.1% 26/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.6% 14/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	17.0% 39/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.4% 17/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Nasopharyngitis	6.1% 33/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.2% 60/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.3% 20/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	17.5% 37/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	12.7% 29/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	17.0% 39/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Pneumonia	3.3% 18/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.5% 19/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.8% 6/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.3% 7/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.5% 8/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.2% 12/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Rhinitis	3.5% 19/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.3% 34/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.2% 9/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.0% 19/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.7% 13/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.7% 20/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Sinusitis	3.2% 17/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.7% 20/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.0% 15/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.5% 18/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.9% 9/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.7% 13/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Infections and infestations Upper Respiratory Tract Infection	3.7% 20/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.5% 40/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.2% 9/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	13.7% 29/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.8% 27/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	15.3% 35/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Investigations Weight Decreased	7.2% 39/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.1% 38/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.4% 3/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 3/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Decreased Appetite	6.7% 36/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.3% 39/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 3/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.6% 6/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Metabolism and nutrition disorders Hypokalaemia	4.3% 23/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.8% 31/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Arthralgia	5.2% 28/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.9% 26/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.2% 24/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.5% 20/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.8% 27/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	13.5% 31/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Back Pain	8.9% 48/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.1% 49/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	14.9% 32/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.0% 19/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	13.5% 31/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.4% 26/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Bone Pain	15.2% 82/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	12.7% 68/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.4% 18/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.4% 24/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.1% 14/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.3% 19/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Muscle Spasms	7.1% 38/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.2% 33/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.7% 10/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.1% 15/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 3/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.9% 9/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	1.7% 9/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.2% 17/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.8% 6/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.8% 8/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.0% 16/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.8% 11/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Myalgia	6.3% 34/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.5% 40/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.3% 7/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.2% 11/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.5% 8/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.7% 20/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Musculoskeletal and connective tissue disorders Pain in Extremity	8.2% 44/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.7% 36/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.4% 3/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.3% 9/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.8% 11/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	7.4% 17/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Dizziness	5.9% 32/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.7% 36/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.2% 5/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Dysgeusia	6.3% 34/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.3% 50/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Headache	7.8% 42/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.2% 44/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.3% 5/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.7% 10/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.5% 8/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.6% 6/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Paraesthesia	21.2% 114/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	23.7% 127/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	10.0% 21/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.4% 10/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.6% 15/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Peripheral Sensory Neuropathy	63.2% 340/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	60.6% 325/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.2% 24/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	14.7% 31/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.8% 27/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	17.0% 39/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Nervous system disorders Tremor	10.8% 58/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	13.4% 72/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.95% 2/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.00% 0/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.87% 2/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Anxiety	8.7% 47/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.4% 61/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.4% 3/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.6% 6/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.3% 3/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Psychiatric disorders Insomnia	15.1% 81/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.9% 64/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.3% 5/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.8% 8/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.2% 5/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.9% 9/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Cough	9.7% 52/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	16.8% 90/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.8% 19/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	19.4% 41/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	10.0% 23/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	17.0% 39/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.7% 63/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	14.6% 78/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.5% 20/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.6% 6/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.9% 9/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	4.6% 25/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.0% 27/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.3% 5/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.4% 3/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.6% 6/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.2% 5/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.3% 23/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.4% 45/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.8% 6/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	10.0% 21/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.4% 10/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.1% 14/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Dry Skin	6.5% 35/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.4% 29/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.6% 6/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.2% 5/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Eczema	1.3% 7/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.4% 18/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.2% 11/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.7% 4/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.1% 7/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Erythema	9.3% 50/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	11.4% 61/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.47% 1/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	6.6% 14/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.44% 1/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.1% 7/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Pruritus	3.2% 17/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.7% 25/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	0.93% 2/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.1% 17/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	2.6% 6/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.1% 7/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Skin and subcutaneous tissue disorders Rash	11.9% 64/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	14.9% 80/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.1% 17/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.1% 7/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	3.5% 8/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
Vascular disorders Hypertension	5.6% 30/538 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	9.5% 51/536 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	1.9% 4/215 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	8.5% 18/211 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	5.7% 13/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.	4.4% 10/229 • AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study. 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. VTd-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. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.

Additional Information

Chief Executive Officier

Intergroupe Francophone du Myélome

Phone: +33 1 40 21 24 02

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60