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NCT03480750 · ADVERSE EVENTS

Adverse events

Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer · Source last updated 2020-11-10

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
All-Cause Mortality was assessed up to 36 months and Serious and Other (non-serious) Adverse Events were assessed within the planned 6-month treatment duration
Other-event reporting threshold
0%

Adverse event severity was graded according to the Common Terminology Criteria for Adverse Events, version 4.03. All participants who received at least one dose of any of the study agents were considered evaluable for safety.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Trientine With Chemotherapy Dose Level 1 (300mg)

trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

0 / 33 / 32 / 3
Trientine With Chemotherapy Dose Level 2 (600mg)

trientine dihydrochloride: trientine dihydrochloride 600MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

0 / 33 / 33 / 3
Trientine With Chemotherapy Dose Level 3 (900mg)

trientine dihydrochloride: trientine dihydrochloride 900MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

1 / 33 / 33 / 3
Trientine With Chemotherapy Dose Level 4 (1200mg)

trientine dihydrochloride: trientine dihydrochloride 1200MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

0 / 33 / 33 / 3
Trientine With Chemotherapy Dose Level 5 (1500mg)

trientine dihydrochloride: trientine dihydrochloride 1500MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

0 / 33 / 33 / 3
Trientine With Chemotherapy Dose Level 6 (1800mg)

trientine dihydrochloride: trientine dihydrochloride 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

0 / 22 / 21 / 2

Group identifiers: EG000: Trientine With Chemotherapy Dose Level 1 (300mg) · EG001: Trientine With Chemotherapy Dose Level 2 (600mg) · EG002: Trientine With Chemotherapy Dose Level 3 (900mg) · EG003: Trientine With Chemotherapy Dose Level 4 (1200mg) · EG004: Trientine With Chemotherapy Dose Level 5 (1500mg) · EG005: Trientine With Chemotherapy Dose Level 6 (1800mg)

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
    notes
    The only grade 4 treatment-related adverse event was thrombocytopenia, which recovered within 7 days.
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    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
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Neutrophil count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      2
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Mucositis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Paresthesia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dizziness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Fatigue
Complete source fields
description
Adverse event severity was graded according to the Common Terminology Criteria for Adverse Events, version 4.03. All participants who received at least one dose of any of the study agents were considered evaluable for safety.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Trientine With Chemotherapy Dose Level 1 (300mg)
  2. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    trientine dihydrochloride: trientine dihydrochloride 600MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Trientine With Chemotherapy Dose Level 2 (600mg)
  3. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    trientine dihydrochloride: trientine dihydrochloride 900MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Trientine With Chemotherapy Dose Level 3 (900mg)
  4. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    trientine dihydrochloride: trientine dihydrochloride 1200MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Trientine With Chemotherapy Dose Level 4 (1200mg)
  5. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    trientine dihydrochloride: trientine dihydrochloride 1500MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Trientine With Chemotherapy Dose Level 5 (1500mg)
  6. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    trientine dihydrochloride: trientine dihydrochloride 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
    id
    EG005
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Trientine With Chemotherapy Dose Level 6 (1800mg)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Neutrophil count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      6
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      5
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      2
    term
    Anemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      3
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Mucositis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Paresthesia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Dizziness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      3
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    The only grade 4 treatment-related adverse event was thrombocytopenia, which recovered within 7 days.
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Thrombocytopenia
time Frame
All-Cause Mortality was assessed up to 36 months and Serious and Other (non-serious) Adverse Events were assessed within the planned 6-month treatment duration

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