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NCT02541383 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma · Source last updated 2025-04-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study.
Other-event reporting threshold
5%

VTd \& DVTd (Part 1) arms contain the SAEs/AEs considered treatment emergent (TEAE) to Part 1 only from the 1st dose and before 2nd rando or subsequent therapy (ST), or after 2nd rando if TEAE related to the Part 1 treatment. VTd-DARA \& DVTd-DARA (Part 2) arms include SAEs/AEs considered TEAE to Part 2, from the 2nd rando up to 30 days after the last dose prior to ST. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
VTd - Part 1

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.

261 / 538529 / 538139 / 542
DVTd - Part 1

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.

264 / 536534 / 53683 / 543
VTd-OBS - Part 2

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.

35 / 215170 / 21548 / 215
VTd-DARA - Part 2

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.

58 / 211194 / 21141 / 211
DVTd-OBS - Part 2

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.

50 / 229198 / 22921 / 229
DVTd-DARA - Part 2

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.

43 / 229205 / 22925 / 229

Group identifiers: EG000: VTd - Part 1 · EG001: DVTd - Part 1 · EG002: VTd-OBS - Part 2 · EG003: VTd-DARA - Part 2 · EG004: DVTd-OBS - Part 2 · EG005: DVTd-DARA - Part 2

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Agranulocytosis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Eosinophilia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Febrile Bone Marrow Aplasia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Febrile Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Haemolytic Uraemic Syndrome
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Histiocytosis Haematophagic
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Leukopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Lymphopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Pancytopenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Thrombocytopenia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      229
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      229
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      229
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      229
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      149
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      229
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      229
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      229
    term
    Vertigo
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      229
    term
    Vision Blurred
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      229
    term
    Abdominal Pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      229
    term
    Abdominal Pain Upper
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      255
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      271
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      229
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      25
      num At Risk
      229
    term
    Diarrhoea
Complete source fields
description
VTd \& DVTd (Part 1) arms contain the SAEs/AEs considered treatment emergent (TEAE) to Part 1 only from the 1st dose and before 2nd rando or subsequent therapy (ST), or after 2nd rando if TEAE related to the Part 1 treatment. VTd-DARA \& DVTd-DARA (Part 2) arms include SAEs/AEs considered TEAE to Part 2, from the 2nd rando up to 30 days after the last dose prior to ST. VTd-OBS \& DVTd-OBS (Part 2) include SAEs/AEs from 2nd rando until 2 years + 30 days but prior to study discontinuation or ST.
event Groups
  1. deaths Num Affected
    139
    deaths Num At Risk
    542
    description
    All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) and who received at least one dose of treatment. 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.
    id
    EG000
    other Num Affected
    529
    other Num At Risk
    538
    serious Num Affected
    261
    serious Num At Risk
    538
    title
    VTd - Part 1
  2. deaths Num Affected
    83
    deaths Num At Risk
    543
    description
    All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) and who received at least one dose of treatment. 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.
    id
    EG001
    other Num Affected
    534
    other Num At Risk
    536
    serious Num Affected
    264
    serious Num At Risk
    536
    title
    DVTd - Part 1
  3. deaths Num Affected
    48
    deaths Num At Risk
    215
    description
    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.
    id
    EG002
    other Num Affected
    170
    other Num At Risk
    215
    serious Num Affected
    35
    serious Num At Risk
    215
    title
    VTd-OBS - Part 2
  4. deaths Num Affected
    41
    deaths Num At Risk
    211
    description
    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.
    id
    EG003
    other Num Affected
    194
    other Num At Risk
    211
    serious Num Affected
    58
    serious Num At Risk
    211
    title
    VTd-DARA - Part 2
  5. deaths Num Affected
    21
    deaths Num At Risk
    229
    description
    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.
    id
    EG004
    other Num Affected
    198
    other Num At Risk
    229
    serious Num Affected
    50
    serious Num At Risk
    229
    title
    DVTd-OBS - Part 2
  6. deaths Num Affected
    25
    deaths Num At Risk
    229
    description
    All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 and to daratumumab group (DARA) at rando 2 and who received at least one dose of treatment after Rando 2. 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.
    id
    EG005
    other Num Affected
    205
    other Num At Risk
    229
    serious Num Affected
    43
    serious Num At Risk
    229
    title
    DVTd-DARA - Part 2
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      229
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      229
    term
    Febrile Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      229
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      229
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      149
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      229
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      229
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      229
    term
    Vertigo
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      229
    term
    Vision Blurred
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      229
    term
    Abdominal Pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      229
    term
    Abdominal Pain Upper
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      255
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      271
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      229
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      25
      num At Risk
      229
    term
    Diarrhoea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Agranulocytosis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Eosinophilia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Febrile Bone Marrow Aplasia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Febrile Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Haemolytic Uraemic Syndrome
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Histiocytosis Haematophagic
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Leukopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Lymphopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Pancytopenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      538
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      536
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      215
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      211
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      229
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      229
    term
    Thrombocytopenia
time Frame
AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study.

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