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NCT00567190 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer · Source last updated 2019-12-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From first treatment dose (12-Feb-2008) through to end of study (23-Nov-2018) for a total safety analysis timeframe of 10 years, 9.5 months.
Other-event reporting threshold
5%

Of enrolled participants (Pertuzumab \[Ptz\]: N=402, Placebo \[Pla\]: N=406), 2 in each arm received no treatment (total of 4), 9 in Pla arm received at least 1 dose of Ptz, and 1 in Ptz arm received Pla at every cycle; resulting in a Safety Population of Ptz: N=408 (402-2+9-1), Pla: N=396 (406-2-9+1), and 50 participants in Pla arm crossed over to Ptz.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo + Trastuzumab + Docetaxel

This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

116 / 396386 / 396261 / 396
Pertuzumab + Trastuzumab + Docetaxel

This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

160 / 408400 / 408238 / 408
Crossover From Placebo to Pertuzumab

Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.

10 / 5045 / 5014 / 50

Group identifiers: EG000: Placebo + Trastuzumab + Docetaxel · EG001: Pertuzumab + Trastuzumab + Docetaxel · EG002: Crossover From Placebo to Pertuzumab

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 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      396
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      408
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      396
      num Events
      23
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      408
      num Events
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Granulocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      396
      num Events
      20
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      408
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      396
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      408
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      408
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Coronary artery disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      396
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      408
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Left ventricular dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      396
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      408
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Ventricular fibrillation

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
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      396
      num Events
      291
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      408
      num Events
      320
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      50
      num Events
      16
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      396
      num Events
      268
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      408
      num Events
      265
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      50
      num Events
      3
    term
    Asthenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      111
      num At Risk
      396
      num Events
      163
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      408
      num Events
      141
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Oedema peripheral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      396
      num Events
      111
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      408
      num Events
      185
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Mucosal inflammation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      396
      num Events
      94
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      408
      num Events
      138
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      50
      num Events
      6
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      396
      num Events
      76
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      408
      num Events
      84
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Oedema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      396
      num Events
      18
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      408
      num Events
      36
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      7
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      396
      num Events
      26
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      408
      num Events
      31
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      191
      num At Risk
      396
      num Events
      428
    2. group Id
      EG001
      num Affected
      277
      num At Risk
      408
      num Events
      989
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      50
      num Events
      155
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      168
      num At Risk
      396
      num Events
      359
    2. group Id
      EG001
      num Affected
      184
      num At Risk
      408
      num Events
      394
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      50
      num Events
      7
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      396
      num Events
      150
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      408
      num Events
      184
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      50
      num Events
      7
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      396
      num Events
      179
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      408
      num Events
      135
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      50
      num Events
      6
    term
    Constipation
Complete source fields
description
Of enrolled participants (Pertuzumab \[Ptz\]: N=402, Placebo \[Pla\]: N=406), 2 in each arm received no treatment (total of 4), 9 in Pla arm received at least 1 dose of Ptz, and 1 in Ptz arm received Pla at every cycle; resulting in a Safety Population of Ptz: N=408 (402-2+9-1), Pla: N=396 (406-2-9+1), and 50 participants in Pla arm crossed over to Ptz.
event Groups
  1. deaths Num Affected
    261
    deaths Num At Risk
    396
    description
    This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    EG000
    other Num Affected
    386
    other Num At Risk
    396
    serious Num Affected
    116
    serious Num At Risk
    396
    title
    Placebo + Trastuzumab + Docetaxel
  2. deaths Num Affected
    238
    deaths Num At Risk
    408
    description
    This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    EG001
    other Num Affected
    400
    other Num At Risk
    408
    serious Num Affected
    160
    serious Num At Risk
    408
    title
    Pertuzumab + Trastuzumab + Docetaxel
  3. deaths Num Affected
    14
    deaths Num At Risk
    50
    description
    Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.
    id
    EG002
    other Num Affected
    45
    other Num At Risk
    50
    serious Num Affected
    10
    serious Num At Risk
    50
    title
    Crossover From Placebo to Pertuzumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      396
      num Events
      291
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      408
      num Events
      320
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      50
      num Events
      16
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      396
      num Events
      268
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      408
      num Events
      265
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      50
      num Events
      3
    term
    Asthenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      111
      num At Risk
      396
      num Events
      163
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      408
      num Events
      141
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Oedema peripheral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      396
      num Events
      111
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      408
      num Events
      185
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Mucosal inflammation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      396
      num Events
      94
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      408
      num Events
      138
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      50
      num Events
      6
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      396
      num Events
      76
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      408
      num Events
      84
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Oedema
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      396
      num Events
      18
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      408
      num Events
      36
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      7
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      396
      num Events
      26
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      408
      num Events
      31
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      191
      num At Risk
      396
      num Events
      428
    2. group Id
      EG001
      num Affected
      277
      num At Risk
      408
      num Events
      989
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      50
      num Events
      155
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      168
      num At Risk
      396
      num Events
      359
    2. group Id
      EG001
      num Affected
      184
      num At Risk
      408
      num Events
      394
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      50
      num Events
      7
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      396
      num Events
      150
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      408
      num Events
      184
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      50
      num Events
      7
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      100
      num At Risk
      396
      num Events
      179
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      408
      num Events
      135
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      50
      num Events
      6
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      396
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      408
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      396
      num Events
      23
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      408
      num Events
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Granulocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      396
      num Events
      20
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      408
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      396
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      408
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      408
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Coronary artery disease
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      396
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      408
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Left ventricular dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      396
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      396
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      408
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      396
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      408
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      50
      num Events
      0
    term
    Ventricular fibrillation
time Frame
From first treatment dose (12-Feb-2008) through to end of study (23-Nov-2018) for a total safety analysis timeframe of 10 years, 9.5 months.

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Preserved source evidence · Not medical advice