Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01847274 · ADVERSE EVENTS

Adverse events

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer · Source last updated 2023-06-02

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, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days
Other-event reporting threshold
5%

Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).

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

Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.

51 / 136136 / 13672 / 136
gBRCA Placebo

Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression

9 / 6562 / 6529 / 65
Non-gBRCA Niraparib

Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.

76 / 231231 / 231146 / 231
Non-gBRCA Placebo

Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression

20 / 114110 / 11468 / 114
FE Niraparib Fasted

Participants received Niraparib 300 mg in fasted condition

1 / 164 / 160 / 16
FE Niraparib Fed

Participants received Niraparib 300 mg in fed condition

0 / 166 / 160 / 16
QTc Sub-study: Niraparib

Participants received Niraparib 300 mg once daily orally.

12 / 2624 / 265 / 26
gBRCA Niraparib (Post-study Unblinding [PSU])

Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

0 / 220 / 220 / 22
gBRCA Placebo (PSU)

Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

0 / 80 / 80 / 8
Non-gBRCA Niraparib (PSU)

Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

0 / 310 / 310 / 31
Non-gBRCA Placebo (PSU)

Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021

0 / 130 / 130 / 13

Group identifiers: EG000: gBRCA Niraparib · EG001: gBRCA Placebo · EG002: Non-gBRCA Niraparib · EG003: Non-gBRCA Placebo · EG004: FE Niraparib Fasted · EG005: FE Niraparib Fed · EG006: QTc Sub-study: Niraparib · EG007: gBRCA Niraparib (Post-study Unblinding [PSU]) · EG008: gBRCA Placebo (PSU) · EG009: Non-gBRCA Niraparib (PSU) · EG010: Non-gBRCA Placebo (PSU)

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      136
      num Events
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      231
      num Events
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      26
      num Events
      9
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      136
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      231
      num Events
      15
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      231
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      231
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      136
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      231
      num Events
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      114
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Small intestinal obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      136
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      114
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      114
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      231
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      114
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      231
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      114
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ileus paralytic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      231
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Intestinal obstruction

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      136
      num Events
      259
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      65
      num Events
      5
    3. group Id
      EG002
      num Affected
      111
      num At Risk
      231
      num Events
      328
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      114
      num Events
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      12
      num At Risk
      26
      num Events
      23
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      136
      num Events
      77
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      65
      num Events
      7
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      231
      num Events
      128
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      114
      num Events
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      26
      num Events
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      136
      num Events
      226
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
      num Events
      3
    3. group Id
      EG002
      num Affected
      93
      num At Risk
      231
      num Events
      256
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      114
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      26
      num Events
      36
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      136
      num Events
      50
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      65
      num Events
      24
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      231
      num Events
      93
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      114
      num Events
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      26
      num Events
      8
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain lower
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      136
      num Events
      105
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      65
      num Events
      14
    3. group Id
      EG002
      num Affected
      96
      num At Risk
      231
      num Events
      163
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      114
      num Events
      30
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      26
      num Events
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      136
      num Events
      71
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      65
      num Events
      28
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      231
      num Events
      76
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      114
      num Events
      34
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      65
      num Events
      3
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      231
      num Events
      17
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      114
      num Events
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Flatulence
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      106
      num At Risk
      136
      num Events
      205
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      65
      num Events
      46
    3. group Id
      EG002
      num Affected
      168
      num At Risk
      231
      num Events
      304
    4. group Id
      EG003
      num Affected
      41
      num At Risk
      114
      num Events
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      26
      num Events
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      136
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      65
      num Events
      4
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      231
      num Events
      18
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      114
      num Events
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      136
      num Events
      96
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      65
      num Events
      13
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      231
      num Events
      126
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      114
      num Events
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      26
      num Events
      11
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Vomiting
Complete source fields
description
Safety Population was used to assess SAEs and non-SAEs, which comprised of all participants who ingested any amount of study drug. The data is presented in separate arms for adverse events before unblinding (data cut-off date of 31-March-2021) and post-study unblinding until the end of study (01-April-2021 to 26-December-2021).
event Groups
  1. deaths Num Affected
    72
    deaths Num At Risk
    136
    description
    Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
    id
    EG000
    other Num Affected
    136
    other Num At Risk
    136
    serious Num Affected
    51
    serious Num At Risk
    136
    title
    gBRCA Niraparib
  2. deaths Num Affected
    29
    deaths Num At Risk
    65
    description
    Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression
    id
    EG001
    other Num Affected
    62
    other Num At Risk
    65
    serious Num Affected
    9
    serious Num At Risk
    65
    title
    gBRCA Placebo
  3. deaths Num Affected
    146
    deaths Num At Risk
    231
    description
    Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
    id
    EG002
    other Num Affected
    231
    other Num At Risk
    231
    serious Num Affected
    76
    serious Num At Risk
    231
    title
    Non-gBRCA Niraparib
  4. deaths Num Affected
    68
    deaths Num At Risk
    114
    description
    Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
    id
    EG003
    other Num Affected
    110
    other Num At Risk
    114
    serious Num Affected
    20
    serious Num At Risk
    114
    title
    Non-gBRCA Placebo
  5. deaths Num Affected
    0
    deaths Num At Risk
    16
    description
    Participants received Niraparib 300 mg in fasted condition
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    16
    serious Num Affected
    1
    serious Num At Risk
    16
    title
    FE Niraparib Fasted
  6. deaths Num Affected
    0
    deaths Num At Risk
    16
    description
    Participants received Niraparib 300 mg in fed condition
    id
    EG005
    other Num Affected
    6
    other Num At Risk
    16
    serious Num Affected
    0
    serious Num At Risk
    16
    title
    FE Niraparib Fed
  7. deaths Num Affected
    5
    deaths Num At Risk
    26
    description
    Participants received Niraparib 300 mg once daily orally.
    id
    EG006
    other Num Affected
    24
    other Num At Risk
    26
    serious Num Affected
    12
    serious Num At Risk
    26
    title
    QTc Sub-study: Niraparib
  8. deaths Num Affected
    0
    deaths Num At Risk
    22
    description
    Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
    id
    EG007
    other Num Affected
    0
    other Num At Risk
    22
    serious Num Affected
    0
    serious Num At Risk
    22
    title
    gBRCA Niraparib (Post-study Unblinding [PSU])
  9. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
    id
    EG008
    other Num Affected
    0
    other Num At Risk
    8
    serious Num Affected
    0
    serious Num At Risk
    8
    title
    gBRCA Placebo (PSU)
  10. deaths Num Affected
    0
    deaths Num At Risk
    31
    description
    Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
    id
    EG009
    other Num Affected
    0
    other Num At Risk
    31
    serious Num Affected
    0
    serious Num At Risk
    31
    title
    Non-gBRCA Niraparib (PSU)
  11. deaths Num Affected
    0
    deaths Num At Risk
    13
    description
    Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021
    id
    EG010
    other Num Affected
    0
    other Num At Risk
    13
    serious Num Affected
    0
    serious Num At Risk
    13
    title
    Non-gBRCA Placebo (PSU)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      136
      num Events
      259
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      65
      num Events
      5
    3. group Id
      EG002
      num Affected
      111
      num At Risk
      231
      num Events
      328
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      114
      num Events
      11
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      12
      num At Risk
      26
      num Events
      23
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      136
      num Events
      77
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      65
      num Events
      7
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      231
      num Events
      128
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      114
      num Events
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      26
      num Events
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      136
      num Events
      226
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
      num Events
      3
    3. group Id
      EG002
      num Affected
      93
      num At Risk
      231
      num Events
      256
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      114
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      0
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
      num Events
      0
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      26
      num Events
      36
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      136
      num Events
      50
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      65
      num Events
      24
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      231
      num Events
      93
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      114
      num Events
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      26
      num Events
      8
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain lower
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      136
      num Events
      105
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      65
      num Events
      14
    3. group Id
      EG002
      num Affected
      96
      num At Risk
      231
      num Events
      163
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      114
      num Events
      30
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      26
      num Events
      12
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      136
      num Events
      71
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      65
      num Events
      28
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      231
      num Events
      76
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      114
      num Events
      34
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      65
      num Events
      3
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      231
      num Events
      17
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      114
      num Events
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Flatulence
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      106
      num At Risk
      136
      num Events
      205
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      65
      num Events
      46
    3. group Id
      EG002
      num Affected
      168
      num At Risk
      231
      num Events
      304
    4. group Id
      EG003
      num Affected
      41
      num At Risk
      114
      num Events
      59
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      13
      num At Risk
      26
      num Events
      16
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      136
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      65
      num Events
      4
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      231
      num Events
      18
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      114
      num Events
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      136
      num Events
      96
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      65
      num Events
      13
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      231
      num Events
      126
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      114
      num Events
      31
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      16
      num Events
      1
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      26
      num Events
      11
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      136
      num Events
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      231
      num Events
      36
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      26
      num Events
      9
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      136
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      231
      num Events
      15
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      26
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      231
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      231
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      136
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      231
      num Events
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      114
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Small intestinal obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      136
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      114
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ascites
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      114
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      231
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      114
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      26
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      231
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      114
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      231
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ileus paralytic
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      231
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      114
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      16
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      26
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      22
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      8
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      31
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Intestinal obstruction
time Frame
All-cause mortality, non-serious AEs (non-SAEs) and SAEs were collected up to 8 years, 6 months and 6 days

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

Preserved source evidence · Not medical advice