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NCT04737187 · ADVERSE EVENTS

Adverse events

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients · Source last updated 2024-09-24

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
Serious AEs and Other AEs: From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months); All-cause mortality: from baseline (Cycle 1 Day 1) up to end of the study (i.e., up to 33.6 months)
Other-event reporting threshold
5%

Analysis was performed on safety set population which included all participants who took at least one dose of FTD/TPI and were analyzed according to the treatment actually received. Reported serious AEs and other AEs were treatment-emergent AEs that developed, worsened or became serious from baseline (Cycle 1 Day 1) up to 30 days after the last dose of the study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Trifluridine/Tipiracil + Bevacizumab

Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.

66 / 246241 / 246208 / 246
Trifluridine/Tipiracil

Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.

79 / 246241 / 246224 / 246

Group identifiers: EG000: Trifluridine/Tipiracil + Bevacizumab · EG001: Trifluridine/Tipiracil

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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      246
    term
    Malignant neoplasm progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Metastases to meninges
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Metastases to spine
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Tumour pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      246
    term
    Metastases to central nervous system
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      246
    term
    Cancer pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      246
    term
    Malignant pleural effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      246
    term
    Metastases to ovary
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      246
    term
    Deep vein thrombosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Pain

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      246
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      246
    term
    Platelet count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      246
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      246
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      246
    term
    Weight decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      246
    term
    Blood bilirubin increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      246
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      246
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      153
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      126
      num At Risk
      246
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      246
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      246
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      246
    term
    Leukopenia
Complete source fields
description
Analysis was performed on safety set population which included all participants who took at least one dose of FTD/TPI and were analyzed according to the treatment actually received. Reported serious AEs and other AEs were treatment-emergent AEs that developed, worsened or became serious from baseline (Cycle 1 Day 1) up to 30 days after the last dose of the study drug.
event Groups
  1. deaths Num Affected
    208
    deaths Num At Risk
    246
    description
    Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.
    id
    EG000
    other Num Affected
    241
    other Num At Risk
    246
    serious Num Affected
    66
    serious Num At Risk
    246
    title
    Trifluridine/Tipiracil + Bevacizumab
  2. deaths Num Affected
    224
    deaths Num At Risk
    246
    description
    Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.
    id
    EG001
    other Num Affected
    241
    other Num At Risk
    246
    serious Num Affected
    79
    serious Num At Risk
    246
    title
    Trifluridine/Tipiracil
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      246
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      246
    term
    Platelet count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      246
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      246
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      246
    term
    Weight decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      246
    term
    Blood bilirubin increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      246
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      246
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      153
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      126
      num At Risk
      246
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      246
    term
    Anaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      246
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      246
    term
    Leukopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      246
    term
    Malignant neoplasm progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Metastases to meninges
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Metastases to spine
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Tumour pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      246
    term
    Metastases to central nervous system
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      246
    term
    Cancer pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      246
    term
    Malignant pleural effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      246
    term
    Metastases to ovary
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      246
    term
    Deep vein thrombosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      246
    term
    Pain
time Frame
Serious AEs and Other AEs: From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months); All-cause mortality: from baseline (Cycle 1 Day 1) up to end of the study (i.e., up to 33.6 months)

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