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NCT01041404 · ADVERSE EVENTS

Adverse events

ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer · Source last updated 2014-11-05

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
Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.
Other-event reporting threshold
5%

The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Fluoropyrimidine/Cisplatin (FP)

Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.

81 / 290279 / 290Not reported / Not reported
Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)

Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.

106 / 294286 / 294Not reported / Not reported

Group identifiers: EG000: Fluoropyrimidine/Cisplatin (FP) · EG001: Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      294
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      294
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      294
    term
    Dysphagia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      294
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      294
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      294
    term
    Gastrointestinal haemorrage
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      294
    term
    Abdominal pain upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      294
    term
    Enteritis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      294
    term
    Gastric haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      294
    term
    Gastric perforation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      294
    term
    Gastrointestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      294
    term
    Ileus

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      189
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      200
      num At Risk
      294
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      146
      num At Risk
      294
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      294
    term
    Diarrhoea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      294
    term
    Constipation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      294
    term
    Stomatitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      294
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      294
    term
    Abdominal pain upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      294
    term
    Dyspepsia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      294
    term
    Dysphagia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      164
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      157
      num At Risk
      294
    term
    Neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      294
    term
    Anaemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      294
    term
    Thrombocytopenia
Complete source fields
description
The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up.
event Groups
  1. description
    Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
    id
    EG000
    other Num Affected
    279
    other Num At Risk
    290
    serious Num Affected
    81
    serious Num At Risk
    290
    title
    Fluoropyrimidine/Cisplatin (FP)
  2. description
    Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
    id
    EG001
    other Num Affected
    286
    other Num At Risk
    294
    serious Num Affected
    106
    serious Num At Risk
    294
    title
    Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      189
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      200
      num At Risk
      294
    term
    Nausea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      146
      num At Risk
      294
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      102
      num At Risk
      294
    term
    Diarrhoea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      294
    term
    Constipation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      294
    term
    Stomatitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      294
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      294
    term
    Abdominal pain upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      294
    term
    Dyspepsia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      294
    term
    Dysphagia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      164
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      157
      num At Risk
      294
    term
    Neutropenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      294
    term
    Anaemia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      294
    term
    Thrombocytopenia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      294
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      294
    term
    Vomiting
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      294
    term
    Dysphagia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      294
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      294
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      294
    term
    Gastrointestinal haemorrage
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      294
    term
    Abdominal pain upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      294
    term
    Enteritis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      294
    term
    Gastric haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      294
    term
    Gastric perforation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      294
    term
    Gastrointestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      290
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      294
    term
    Ileus
time Frame
Adverse events were recorded from study start to 6 months after treatment completion. Drug-related Serious Adverse Events are collected through study and follow-up regardless of the time elapsed, or if the study has been closed.

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