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NCT02445391 · ADVERSE EVENTS

Adverse events

Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy · Source last updated 2026-07-27

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
Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization.
Other-event reporting threshold
5%

Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Observation)

Patients were on observation and did not receive any treatment.

0 / 00 / 02 / 3
Arm B (Cisplatin or Carboplatin)

Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV

50 / 186141 / 18651 / 199
Arm C (Capecitabine)

Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO

32 / 201165 / 20145 / 213

Group identifiers: EG000: Arm A (Observation) · EG001: Arm B (Cisplatin or Carboplatin) · EG002: Arm C (Capecitabine)

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
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
    term
    Hearing impaired
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
    term
    Thrombotic thrombocytopenic purpura
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
    term
    Blood and lymphatic system disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
    term
    Cardiac disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      201
    term
    Death NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      201
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
    term
    General disorders and administration site conditions - Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      201
    term
    Palmar-plantar erythrodysesthesia syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      201
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      201
    term
    Diarrhea

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      201
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      201
    term
    Alopecia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      113
      num At Risk
      201
    term
    Palmar-plantar erythrodysesthesia syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      201
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      90
      num At Risk
      201
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      80
      num At Risk
      201
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      201
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      201
    term
    White blood cell decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      201
    term
    Peripheral sensory neuropathy
Complete source fields
description
Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Patients were on observation and did not receive any treatment.
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Arm A (Observation)
  2. deaths Num Affected
    51
    deaths Num At Risk
    199
    description
    Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV
    id
    EG001
    other Num Affected
    141
    other Num At Risk
    186
    serious Num Affected
    50
    serious Num At Risk
    186
    title
    Arm B (Cisplatin or Carboplatin)
  3. deaths Num Affected
    45
    deaths Num At Risk
    213
    description
    Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
    id
    EG002
    other Num Affected
    165
    other Num At Risk
    201
    serious Num Affected
    32
    serious Num At Risk
    201
    title
    Arm C (Capecitabine)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      201
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      201
    term
    Alopecia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      113
      num At Risk
      201
    term
    Palmar-plantar erythrodysesthesia syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      201
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      90
      num At Risk
      201
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      80
      num At Risk
      201
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      201
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      201
    term
    White blood cell decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      201
    term
    Peripheral sensory neuropathy
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
    term
    Hearing impaired
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
    term
    Thrombotic thrombocytopenic purpura
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      201
    term
    Blood and lymphatic system disorders - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
    term
    Cardiac disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      201
    term
    Death NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      201
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      201
    term
    General disorders and administration site conditions - Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      201
    term
    Palmar-plantar erythrodysesthesia syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      201
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num At Risk
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      186
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      201
    term
    Diarrhea
time Frame
Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization.

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