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NCT00976911 · ADVERSE EVENTS

Adverse events

AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer · Source last updated 2022-06-21

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 recorded at every treatment visit and all follow-up visits until 2 months after the final follow-up visit (up to approximately 4 years).
Other-event reporting threshold
5%

Only Grade 2-5 AEs according to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) were recorded per the protocol. The safety population included all treated participants.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Chemotherapy

Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.

49 / 181129 / 181Not reported / Not reported
Chemotherapy + Bevacizumab

Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.

56 / 179146 / 179Not reported / Not reported

Group identifiers: EG000: Chemotherapy · EG001: Chemotherapy + Bevacizumab

Serious adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCTCAE, Version 3.0,
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      179
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      179
    term
    Ileus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      179
    term
    Subileus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      179
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      179
    term
    Small intestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      179
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      179
    term
    Pyrexia

Other reported adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCTCAE, Version 3.0,
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      179
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      179
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      179
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      179
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      179
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      179
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      179
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      179
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      179
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      179
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      179
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      179
    term
    Mucosal inflammation
Complete source fields
description
Only Grade 2-5 AEs according to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) were recorded per the protocol. The safety population included all treated participants.
event Groups
  1. description
    Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
    id
    EG000
    other Num Affected
    129
    other Num At Risk
    181
    serious Num Affected
    49
    serious Num At Risk
    181
    title
    Chemotherapy
  2. description
    Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
    id
    EG001
    other Num Affected
    146
    other Num At Risk
    179
    serious Num Affected
    56
    serious Num At Risk
    179
    title
    Chemotherapy + Bevacizumab
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCTCAE, Version 3.0,
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      179
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      179
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      179
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      179
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      179
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      179
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      179
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      179
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      179
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      179
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      179
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      179
    term
    Mucosal inflammation
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCTCAE, Version 3.0,
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      179
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      179
    term
    Ileus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      179
    term
    Subileus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      179
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      179
    term
    Small intestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Ascites
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      179
    term
    General physical health deterioration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 15.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      181
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      179
    term
    Pyrexia
time Frame
Adverse Events (AEs) were recorded at every treatment visit and all follow-up visits until 2 months after the final follow-up visit (up to approximately 4 years).

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