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NCT02953340 · ADVERSE EVENTS

Adverse events

SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide · 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
Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
Other-event reporting threshold
5%

The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.

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

At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg / 0.6 mL, \[3.6 mg G-CSF\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 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.

12 / 117115 / 1170 / 117
(Arm 2): Pegfilgrastim and TC

At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 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.

19 / 118116 / 1181 / 118
(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 study treatment.

2 / 11733 / 1170 / 117
(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 study treatment.

4 / 11848 / 1180 / 118

Group identifiers: EG000: (Arm 1): SPI-2012 and TC · EG001: (Arm 2): Pegfilgrastim and TC · 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
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Deep vein thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Administration site reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Delirium
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Fall
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Ligament sprain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Rib fracture
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      118
    term
    Seroma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Neutrophil count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    White blood cell count decreased

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
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      118
    term
    Flushing
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      118
    term
    Hot flush
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      118
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Hypotension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      118
    term
    Oedema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      118
    term
    Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      118
    term
    Chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      118
    term
    Insomnia
Complete source fields
description
The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    117
    description
    At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg / 0.6 mL, \[3.6 mg G-CSF\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 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
    115
    other Num At Risk
    117
    serious Num Affected
    12
    serious Num At Risk
    117
    title
    (Arm 1): SPI-2012 and TC
  2. deaths Num Affected
    1
    deaths Num At Risk
    118
    description
    At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 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
    116
    other Num At Risk
    118
    serious Num Affected
    19
    serious Num At Risk
    118
    title
    (Arm 2): Pegfilgrastim and TC
  3. deaths Num Affected
    0
    deaths Num At Risk
    117
    description
    In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
    id
    EG002
    other Num Affected
    33
    other Num At Risk
    117
    serious Num Affected
    2
    serious Num At Risk
    117
    title
    (Arm 1): SPI-2012 and TC: Follow-up Period
  4. deaths Num Affected
    0
    deaths Num At Risk
    118
    description
    In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.
    id
    EG003
    other Num Affected
    48
    other Num At Risk
    118
    serious Num Affected
    4
    serious Num At Risk
    118
    title
    (Arm 2): Pegfilgrastim and TC: Follow-up Period
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      118
    term
    Flushing
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      118
    term
    Hot flush
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      118
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Hypotension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      118
    term
    Oedema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Asthenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      118
    term
    Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      118
    term
    Chills
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      118
    term
    Insomnia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Deep vein thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Administration site reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Pyrexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Delirium
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Fall
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Ligament sprain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Rib fracture
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      118
    term
    Seroma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    Neutrophil count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      117
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      118
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      117
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      118
    term
    White blood cell count decreased
time Frame
Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)

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

Preserved source evidence · Not medical advice