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NCT01853748 · ADVERSE EVENTS

Adverse events

T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) · Source last updated 2026-02-19

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
AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years. The AE data cutoff date is 21 April 2020.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Trastuzumab Emtansine (T-DM1)

T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks

62 / 383383 / 3836 / 383
Paclitaxel + Trastuzumab

paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments

26 / 114114 / 1141 / 114

Group identifiers: EG000: Trastuzumab Emtansine (T-DM1) · EG001: Paclitaxel + Trastuzumab

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
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      114
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Left ventricular systolic dysfunction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      114
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      114
    term
    Infusion related reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Hyperhidrosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      114
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Gastric hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Nausea

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
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Ear pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Hearing impaired
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Tinnitus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Tinnitus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      114
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Vestibular disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Ear and labyrinth disorders - Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      114
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      114
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Leukocytosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Lymph node pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Thrombotic thrombocytopenic purpura
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    383
    description
    T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
    id
    EG000
    other Num Affected
    383
    other Num At Risk
    383
    serious Num Affected
    62
    serious Num At Risk
    383
    title
    Trastuzumab Emtansine (T-DM1)
  2. deaths Num Affected
    1
    deaths Num At Risk
    114
    description
    paclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
    id
    EG001
    other Num Affected
    114
    other Num At Risk
    114
    serious Num Affected
    26
    serious Num At Risk
    114
    title
    Paclitaxel + Trastuzumab
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Ear pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Hearing impaired
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Tinnitus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Tinnitus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      114
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Vestibular disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Ear and labyrinth disorders - Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      114
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      114
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Leukocytosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Lymph node pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Thrombotic thrombocytopenic purpura
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      114
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Left ventricular systolic dysfunction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      114
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      114
    term
    Infusion related reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Hyperhidrosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      114
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Gastric hemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      383
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      114
    term
    Nausea
time Frame
AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years. The AE data cutoff date is 21 April 2020.

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