Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00628251 · ADVERSE EVENTS

Adverse events

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer · Source last updated 2019-12-05

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
Not reported
Other-event reporting threshold
5%

AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Olaparib 200 mg bd

Olaparib (AZD2281) 200 mg oral capsules twice daily

5 / 3232 / 32Not reported / Not reported
Olaparib 400 mg bd

Olaparib (AZD2281) 400 mg oral capsules twice daily

6 / 3232 / 32Not reported / Not reported
Liposomal Doxorubicin

Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks

5 / 3231 / 32Not reported / Not reported

Group identifiers: EG000: Olaparib 200 mg bd · EG001: Olaparib 400 mg bd · EG002: Liposomal Doxorubicin

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Vomiting
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Abdominal Pain Lower
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Intestinal Obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Small Intestinal Obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Subileus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Cholelithiasis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Bacteraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Overdose

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 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      32
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Dry Eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      32
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      32
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      32
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      32
    term
    Abdominal Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      32
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      32
    term
    Diarrhoea
Complete source fields
description
AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
event Groups
  1. description
    Olaparib (AZD2281) 200 mg oral capsules twice daily
    id
    EG000
    other Num Affected
    32
    other Num At Risk
    32
    serious Num Affected
    5
    serious Num At Risk
    32
    title
    Olaparib 200 mg bd
  2. description
    Olaparib (AZD2281) 400 mg oral capsules twice daily
    id
    EG001
    other Num Affected
    32
    other Num At Risk
    32
    serious Num Affected
    6
    serious Num At Risk
    32
    title
    Olaparib 400 mg bd
  3. description
    Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
    id
    EG002
    other Num Affected
    31
    other Num At Risk
    32
    serious Num Affected
    5
    serious Num At Risk
    32
    title
    Liposomal Doxorubicin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      32
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      32
    term
    Dry Eye
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      32
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      32
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      32
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      32
    term
    Abdominal Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      32
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      32
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Vomiting
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Abdominal Pain Lower
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Intestinal Obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Small Intestinal Obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Subileus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      32
    term
    Cholelithiasis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Bacteraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      32
    term
    Overdose

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice