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NCT01272037 · ADVERSE EVENTS

Adverse events

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer · Source last updated 2026-08-28

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 assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Other-event reporting threshold
5%

Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Chemo and Endocrine Therapy

Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.

14 / 2062151 / 2062161 / 2487
Endocrine Therapy Alone

Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.

9 / 23422 / 2342175 / 2497

Group identifiers: EG000: Chemo and Endocrine Therapy · EG001: Endocrine Therapy Alone

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2342
    term
    Cardiac arrest
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Gastrointestinal disorders-Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Typhlitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Upper gastrointestinal hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2342
    term
    Death NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2342
    term
    Multi-organ failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Device related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Injury, poison and procedural complications - Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Leukemia secondary to oncology chemotherapy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2342
    term
    Neoplasms benign, malignant and unspecified - Other

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
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      151
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2342
    term
    Neutrophil count decreased
Complete source fields
description
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
event Groups
  1. deaths Num Affected
    161
    deaths Num At Risk
    2487
    description
    Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    151
    other Num At Risk
    2062
    serious Num Affected
    14
    serious Num At Risk
    2062
    title
    Chemo and Endocrine Therapy
  2. deaths Num Affected
    175
    deaths Num At Risk
    2497
    description
    Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2342
    serious Num Affected
    9
    serious Num At Risk
    2342
    title
    Endocrine Therapy Alone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      151
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2342
    term
    Neutrophil count decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2342
    term
    Cardiac arrest
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Gastrointestinal disorders-Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Typhlitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Upper gastrointestinal hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2342
    term
    Death NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2342
    term
    Multi-organ failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Device related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Sepsis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Injury, poison and procedural complications - Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2342
    term
    Leukemia secondary to oncology chemotherapy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2062
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2342
    term
    Neoplasms benign, malignant and unspecified - Other
time Frame
Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.

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Preserved source evidence · Not medical advice