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NCT04689828 · ADVERSE EVENTS

Adverse events

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer · Source last updated 2026-08-26

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
From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization.
Other-event reporting threshold
5%

Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
177Lu-PSMA-617

Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.

46 / 227217 / 227142 / 234
Androgen Receptor-directed Therapy (ARDT)

For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.

76 / 232208 / 232157 / 234

Group identifiers: EG000: 177Lu-PSMA-617 · EG001: Androgen Receptor-directed Therapy (ARDT)

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 (27.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      232
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Blood loss anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Aortic valve disease mixed
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    term
    Cardiac failure

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 (27.1)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      232
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      232
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      232
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      232
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      232
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      232
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      232
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      232
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      232
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      232
    term
    Oedema peripheral
Complete source fields
description
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Analysis Set was assessed for Serious and Other Adverse Events during the randomized On-Treatment Period.
event Groups
  1. deaths Num Affected
    142
    deaths Num At Risk
    234
    description
    Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.
    id
    EG000
    other Num Affected
    217
    other Num At Risk
    227
    serious Num Affected
    46
    serious Num At Risk
    227
    title
    177Lu-PSMA-617
  2. deaths Num Affected
    157
    deaths Num At Risk
    234
    description
    For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
    id
    EG001
    other Num Affected
    208
    other Num At Risk
    232
    serious Num Affected
    76
    serious Num At Risk
    232
    title
    Androgen Receptor-directed Therapy (ARDT)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      232
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      232
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      232
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      232
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      232
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      232
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      232
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      232
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      232
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      232
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      232
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      232
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Blood loss anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Aortic valve disease mixed
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      232
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      227
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      232
    term
    Cardiac failure
time Frame
From start of study drug to max (30 days after EOT or last AAA617 dose date+41 days, last ARDT dose+30 days) or day before crossover up to data cut-off, max. of 42 months from randomization.

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