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NCT01566721 · ADVERSE EVENTS

Adverse events

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer · Source last updated 2021-04-27

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
Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Other-event reporting threshold
5%

Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A: SC Herceptin by Needle/Syringe

Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.

242 / 18641499 / 1864Not reported / Not reported
Cohort B: SC Herceptin by SID

Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

84 / 709576 / 709Not reported / Not reported
Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up

Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.

202 / 18620 / 1862Not reported / Not reported
Cohort B: SC Herceptin by SID Safety Follow-up

Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

53 / 7070 / 707Not reported / Not reported

Group identifiers: EG000: Cohort A: SC Herceptin by Needle/Syringe · EG001: Cohort B: SC Herceptin by SID · EG002: Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up · EG003: Cohort B: SC Herceptin by SID Safety Follow-up

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
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Neutropenic sepsis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1862
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Device related infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      1864
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      1862
      num Events
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      707
      num Events
      2
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1862
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Urinary tract infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      1862
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Mastitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      1862
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      707
      num Events
      1
    term
    Cellulitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Gastroenteritis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Lower respiratory tract infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1862
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Appendicitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Upper respiratory tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1862
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Breast abscess
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Erysipelas

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
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      381
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      221
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Asthenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Pyrexia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Oedema peripheral
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      128
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Injection site erythema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Mucosal inflammation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      117
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Injection site pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Injection site reaction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      362
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      133
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Arthralgia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      260
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Myalgia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Pain in extremity
Complete source fields
description
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
event Groups
  1. description
    Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
    id
    EG000
    other Num Affected
    1499
    other Num At Risk
    1864
    serious Num Affected
    242
    serious Num At Risk
    1864
    title
    Cohort A: SC Herceptin by Needle/Syringe
  2. description
    Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
    id
    EG001
    other Num Affected
    576
    other Num At Risk
    709
    serious Num Affected
    84
    serious Num At Risk
    709
    title
    Cohort B: SC Herceptin by SID
  3. description
    Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    1862
    serious Num Affected
    202
    serious Num At Risk
    1862
    title
    Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up
  4. description
    Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    707
    serious Num Affected
    53
    serious Num At Risk
    707
    title
    Cohort B: SC Herceptin by SID Safety Follow-up
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      381
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Fatigue
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      221
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Asthenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Pyrexia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Oedema peripheral
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      128
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Injection site erythema
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Mucosal inflammation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      117
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Injection site pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Injection site reaction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      362
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      133
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Arthralgia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      260
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Myalgia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Pain in extremity
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Neutropenic sepsis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1862
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Device related infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      1864
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      1862
      num Events
      8
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      707
      num Events
      2
    term
    Pneumonia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1862
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Urinary tract infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      1862
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Mastitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      1862
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      707
      num Events
      1
    term
    Cellulitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Gastroenteritis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Lower respiratory tract infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1862
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Appendicitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Upper respiratory tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1862
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
      num Events
      0
    term
    Breast abscess
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1864
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      709
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1862
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      707
    term
    Erysipelas
time Frame
Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)

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

Preserved source evidence · Not medical advice