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NCT00545688 · ADVERSE EVENTS

Adverse events

A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer. · Source last updated 2017-08-15

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

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

Collection time frame
Adverse events were recorded from the date of Screening until the clinical cut off date 20th October 2014 up to 7 years.
Other-event reporting threshold
5%

The safety population included all participants who received at least one dose of study medication and at least one safety assessment performed at baseline. Participants were assigned to treatment groups according to treatment actually received.

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

Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.

21 / 107107 / 107Not reported / Not reported
Trastuzumab+Pertuzumab+Docetaxel

Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.

22 / 107105 / 107Not reported / Not reported
Trastuzumab+Pertuzumab

Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.

19 / 108101 / 108Not reported / Not reported
Pertuzumab+Docetaxel

Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.

21 / 9494 / 94Not reported / Not reported

Group identifiers: EG000: Trastuzumab+Docetaxel · EG001: Trastuzumab+Pertuzumab+Docetaxel · EG002: Trastuzumab+Pertuzumab · EG003: Pertuzumab+Docetaxel

Serious adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      94
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      94
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Neutropenic infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Appendicitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Pyelonephritis acute
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Urinary tract infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Wound infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Breast abscess
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      94
    term
    Cellulitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Device related infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    H1N1 influenza
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Infection

Other reported adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      52
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      61
      num At Risk
      94
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      94
    term
    Diarrhoea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      37
      num At Risk
      94
    term
    Vomiting
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      94
    term
    Stomatitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      94
    term
    Abdominal pain upper
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      94
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      94
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      94
    term
    Haemorrhoids
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      94
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      94
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      59
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      65
      num At Risk
      94
    term
    Alopecia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      94
    term
    Rash
Complete source fields
description
The safety population included all participants who received at least one dose of study medication and at least one safety assessment performed at baseline. Participants were assigned to treatment groups according to treatment actually received.
event Groups
  1. description
    Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
    id
    EG000
    other Num Affected
    107
    other Num At Risk
    107
    serious Num Affected
    21
    serious Num At Risk
    107
    title
    Trastuzumab+Docetaxel
  2. description
    Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
    id
    EG001
    other Num Affected
    105
    other Num At Risk
    107
    serious Num Affected
    22
    serious Num At Risk
    107
    title
    Trastuzumab+Pertuzumab+Docetaxel
  3. description
    Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.
    id
    EG002
    other Num Affected
    101
    other Num At Risk
    108
    serious Num Affected
    19
    serious Num At Risk
    108
    title
    Trastuzumab+Pertuzumab
  4. description
    Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.
    id
    EG003
    other Num Affected
    94
    other Num At Risk
    94
    serious Num Affected
    21
    serious Num At Risk
    94
    title
    Pertuzumab+Docetaxel
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      52
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      61
      num At Risk
      94
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      94
    term
    Diarrhoea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      37
      num At Risk
      94
    term
    Vomiting
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      94
    term
    Stomatitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      94
    term
    Abdominal pain upper
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      94
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      94
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      94
    term
    Haemorrhoids
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      94
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      94
    term
    Abdominal distension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      59
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      65
      num At Risk
      94
    term
    Alopecia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      94
    term
    Rash
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      94
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      94
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Neutropenic infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Appendicitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Pyelonephritis acute
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Urinary tract infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Wound infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Breast abscess
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      94
    term
    Cellulitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Device related infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    H1N1 influenza
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      107
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      107
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      108
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      94
    term
    Infection
time Frame
Adverse events were recorded from the date of Screening until the clinical cut off date 20th October 2014 up to 7 years.

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Preserved source evidence · Not medical advice