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NCT01942135 · ADVERSE EVENTS

Adverse events

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) · Source last updated 2024-04-04

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
From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).
Other-event reporting threshold
5%

The safety analysis set for adverse events and serious adverse events included all participants who received at least 1 dose of study intervention, with treatment assignments designated according to actual study intervention received. All-cause mortality of the total number at risk included all participants who were randomized, with study intervention, regardless of whether participants received the study intervention or received a different drug from that to which they were randomized.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Palbociclib + Fulvestrant

Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.

78 / 345341 / 345201 / 347
Placebo + Fulvestrant

Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.

33 / 172161 / 172109 / 174

Group identifiers: EG000: Palbociclib + Fulvestrant · EG001: Placebo + Fulvestrant

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 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Disseminated intravascular coagulation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Pericarditis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Hyperthyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      172
    term
    Ascites
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Duodenal ulcer
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      172
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      172
    term
    Pancreatitis

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      172
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      172
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      231
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      172
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      172
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      172
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      172
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      172
    term
    Dry mouth
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      172
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      126
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      172
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      172
    term
    Stomatitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      172
    term
    Vomiting
Complete source fields
description
The safety analysis set for adverse events and serious adverse events included all participants who received at least 1 dose of study intervention, with treatment assignments designated according to actual study intervention received. All-cause mortality of the total number at risk included all participants who were randomized, with study intervention, regardless of whether participants received the study intervention or received a different drug from that to which they were randomized.
event Groups
  1. deaths Num Affected
    201
    deaths Num At Risk
    347
    description
    Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
    id
    EG000
    other Num Affected
    341
    other Num At Risk
    345
    serious Num Affected
    78
    serious Num At Risk
    345
    title
    Palbociclib + Fulvestrant
  2. deaths Num Affected
    109
    deaths Num At Risk
    174
    description
    Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
    id
    EG001
    other Num Affected
    161
    other Num At Risk
    172
    serious Num Affected
    33
    serious Num At Risk
    172
    title
    Placebo + Fulvestrant
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      172
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      172
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      231
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      172
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      172
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      172
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      172
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      172
    term
    Dry mouth
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      172
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      126
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      172
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      172
    term
    Stomatitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      172
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Disseminated intravascular coagulation
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Atrial fibrillation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Pericarditis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Hyperthyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      172
    term
    Ascites
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Duodenal ulcer
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      172
    term
    Intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      172
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      345
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      172
    term
    Pancreatitis
time Frame
From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).

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