Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02643420 · ADVERSE EVENTS

Adverse events

SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) · Source last updated 2022-03-02

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 first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)
Other-event reporting threshold
5%

The safety population included all participants who had received at least one dose of any protocol specified drug (TC, SPI-2012, or pegfilgrastim). One participant was randomized to pegfilgrastim received SPI-2012 and was included in the Safety Population. Adverse events data was summarized and reported separately for the Treatment Period and Follow-up Period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1: SPI-2012 and TC -Treatment Period

Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.

36 / 197192 / 1970 / 197
Arm 2: Pegfilgrastim and TC -Treatment Period

Participants received Pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.

29 / 208203 / 2081 / 208
Arm 1: SPI-2012 and TC - Follow up Period

In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.

8 / 19792 / 1970 / 197
Arm 2: Pegfilgrastim and TC - Follow up Period

In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.

2 / 20882 / 2081 / 208

Group identifiers: EG000: Arm 1: SPI-2012 and TC -Treatment Period · EG001: Arm 2: Pegfilgrastim and TC -Treatment Period · EG002: Arm 1: SPI-2012 and TC - Follow up Period · EG003: Arm 2: Pegfilgrastim and TC - Follow up Period

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      208
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Ventricular arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Gastrointestinal haemorrhage

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
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      208
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      208
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      208
    term
    Oedema peripheral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Asthenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Mucosal inflammation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      104
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      208
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      208
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      208
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      208
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      208
    term
    Stomatitis
Complete source fields
description
The safety population included all participants who had received at least one dose of any protocol specified drug (TC, SPI-2012, or pegfilgrastim). One participant was randomized to pegfilgrastim received SPI-2012 and was included in the Safety Population. Adverse events data was summarized and reported separately for the Treatment Period and Follow-up Period.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    197
    description
    Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
    id
    EG000
    other Num Affected
    192
    other Num At Risk
    197
    serious Num Affected
    36
    serious Num At Risk
    197
    title
    Arm 1: SPI-2012 and TC -Treatment Period
  2. deaths Num Affected
    1
    deaths Num At Risk
    208
    description
    Participants received Pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.
    id
    EG001
    other Num Affected
    203
    other Num At Risk
    208
    serious Num Affected
    29
    serious Num At Risk
    208
    title
    Arm 2: Pegfilgrastim and TC -Treatment Period
  3. deaths Num Affected
    0
    deaths Num At Risk
    197
    description
    In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
    id
    EG002
    other Num Affected
    92
    other Num At Risk
    197
    serious Num Affected
    8
    serious Num At Risk
    197
    title
    Arm 1: SPI-2012 and TC - Follow up Period
  4. deaths Num Affected
    1
    deaths Num At Risk
    208
    description
    In addition to the treatment period, long-term safety follow-up continued for 12 months after last dose of study treatment.
    id
    EG003
    other Num Affected
    82
    other Num At Risk
    208
    serious Num Affected
    2
    serious Num At Risk
    208
    title
    Arm 2: Pegfilgrastim and TC - Follow up Period
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      208
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      208
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      208
    term
    Oedema peripheral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Asthenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Mucosal inflammation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Chills
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      104
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      208
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      208
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      208
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      208
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      208
    term
    Stomatitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      208
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Ventricular arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      197
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      208
    term
    Gastrointestinal haemorrhage
time Frame
From the first dose of TC (Docetaxel + Cyclophosphamide) until 12 months after the last dose of study treatment (up to approximately 34 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice