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NCT00555906 · ADVERSE EVENTS

Adverse events

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma. · Source last updated 2015-03-19

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
Not reported
Other-event reporting threshold
0%

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)

Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

0 / 33 / 3Not reported / Not reported
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)

Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

3 / 66 / 6Not reported / Not reported
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)

Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

0 / 77 / 7Not reported / Not reported
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)

Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

5 / 55 / 5Not reported / Not reported
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)

Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

10 / 3030 / 30Not reported / Not reported

Group identifiers: EG000: Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A) · EG001: Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A) · EG002: Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B) · EG003: Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B) · EG004: Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)

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 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Dysphagia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
    term
    Pyrexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
    term
    Bacteraemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Sepsis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Blood creatinine increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Metabolic acidosis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Back pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Central nervous system haemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Respiratory failure

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 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      30
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Hyperviscosity syndrome
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      30
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      30
    term
    Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      30
    term
    Thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Ear pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Blepharitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Chalazion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
    term
    Conjunctivitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Dry eye
Complete source fields
description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
event Groups
  1. description
    Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
  2. description
    Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
  3. description
    Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    0
    serious Num At Risk
    7
    title
    Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
  4. description
    Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    5
    serious Num At Risk
    5
    title
    Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
  5. description
    Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    EG004
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    10
    serious Num At Risk
    30
    title
    Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      30
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Hyperviscosity syndrome
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      30
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
    term
    Lymphopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      30
    term
    Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      30
    term
    Thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Ear pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Blepharitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Chalazion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
    term
    Conjunctivitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Dry eye
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      30
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Dysphagia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      30
    term
    Pyrexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      30
    term
    Bacteraemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Sepsis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Blood creatinine increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Metabolic acidosis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Back pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Central nervous system haemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 16.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      30
    term
    Respiratory failure

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