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NCT03511664 · ADVERSE EVENTS

Adverse events

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer · Source last updated 2025-01-13

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
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 43 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 66 months.
Other-event reporting threshold
5%

Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)

Main Study: 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) - Events up to 30 days post-treatment

195 / 529502 / 52968 / 551
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone

Main Study: Best supportive/best standard of care (BS/BSOC) alone - Events up to 30 days post-treatment

58 / 205151 / 20519 / 280
Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)

non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study

9 / 3028 / 305 / 30
Main Study (Post-Tx Survival FU): 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care(BS/BSOC)

Main Study (Post-Treatment Survival Follow-Up): 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) - Deaths in the post-treatment survival follow-up were not considered adverse events.

0 / 00 / 0389 / 461
Main Study (Post-Tx Survival FU): Best Supportive/Best Standard of Care (BS/BSOC) Alone

Main Study (Post-Treatment Survival Follow-Up): Best supportive/best standard of care (BS/BSOC) alone - Deaths in the post-treatment survival follow-up were not considered adverse events.

0 / 00 / 0182 / 186
Sub Study (Post-Tx Survival FU): 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)

Sub Study (Post-Treatment Survival Follow-Up): 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) - Deaths in the post-treatment survival follow-up were not considered adverse events.

0 / 00 / 016 / 25

Group identifiers: EG000: Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) · EG001: Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone · EG002: Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) · EG003: Main Study (Post-Tx Survival FU): 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care(BS/BSOC) · EG004: Main Study (Post-Tx Survival FU): Best Supportive/Best Standard of Care (BS/BSOC) Alone · EG005: Sub Study (Post-Tx Survival FU): 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardio-respiratory arrest

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      161
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      205
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Flatulence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      187
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Toothache
Complete source fields
description
Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included patients who entered this period. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication.
event Groups
  1. deaths Num Affected
    68
    deaths Num At Risk
    551
    description
    Main Study: 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) - Events up to 30 days post-treatment
    id
    EG000
    other Num Affected
    502
    other Num At Risk
    529
    serious Num Affected
    195
    serious Num At Risk
    529
    title
    Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
  2. deaths Num Affected
    19
    deaths Num At Risk
    280
    description
    Main Study: Best supportive/best standard of care (BS/BSOC) alone - Events up to 30 days post-treatment
    id
    EG001
    other Num Affected
    151
    other Num At Risk
    205
    serious Num Affected
    58
    serious Num At Risk
    205
    title
    Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
  3. deaths Num Affected
    5
    deaths Num At Risk
    30
    description
    non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study
    id
    EG002
    other Num Affected
    28
    other Num At Risk
    30
    serious Num Affected
    9
    serious Num At Risk
    30
    title
    Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
  4. deaths Num Affected
    389
    deaths Num At Risk
    461
    description
    Main Study (Post-Treatment Survival Follow-Up): 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) - Deaths in the post-treatment survival follow-up were not considered adverse events.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Main Study (Post-Tx Survival FU): 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care(BS/BSOC)
  5. deaths Num Affected
    182
    deaths Num At Risk
    186
    description
    Main Study (Post-Treatment Survival Follow-Up): Best supportive/best standard of care (BS/BSOC) alone - Deaths in the post-treatment survival follow-up were not considered adverse events.
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Main Study (Post-Tx Survival FU): Best Supportive/Best Standard of Care (BS/BSOC) Alone
  6. deaths Num Affected
    16
    deaths Num At Risk
    25
    description
    Sub Study (Post-Treatment Survival Follow-Up): 177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC) - Deaths in the post-treatment survival follow-up were not considered adverse events.
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Sub Study (Post-Tx Survival FU): 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      161
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      205
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Flatulence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      187
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Toothache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      529
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      205
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
    4. group Id
      EG003
      num At Risk
      0
    5. group Id
      EG004
      num At Risk
      0
    6. group Id
      EG005
      num At Risk
      0
    term
    Cardio-respiratory arrest
time Frame
Adverse Events (AEs) were collected from first dose of study medication until the last dose plus 30 days post-treat follow-up, assessed up to approximately 43 months. Deaths were recorded from study start date until end of survival follow-up phase (end of study), assessed up to approximately 66 months.

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