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NCT03875235 · ADVERSE EVENTS

Adverse events

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) · Source last updated 2026-08-26

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: from first dose of study medication up to 90 days after the last dose of study medication or until the initiation of the first subsequent therapy (whichever comes first), up to maximum of approximately 67 months. All-cause mortality (death due to any cause): from randomization up to analysis DCO (28 February 2025). Maximum timeframe of approximately 67 months.
Other-event reporting threshold
5%

There were 341 patients randomized to Durvalumab + Gemcitabine + Cisplatin and 344 patients randomized to Placebo + Gemcitabine + Cisplatin (Full Analysis Set). Five of these patients did not receive treatment (resulting in 338 in Durvalumab arm and 342 in Placebo arm for Safety Analysis Set). Hence, the Total numbers at risk for all-cause mortality is 341 (Durvalumab) and 344 (Placebo), while the Total number at Risk by any Serious/Other Adverse Event is 338 (Durvalumab) and 342 (Placebo).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Durvalumab + Gemcitabine + Cisplatin

Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

168 / 338326 / 338308 / 341
Placebo + Gemcitabine + Cisplatin

Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

152 / 342330 / 342326 / 344

Group identifiers: EG000: Durvalumab + Gemcitabine + Cisplatin · EG001: Placebo + Gemcitabine + Cisplatin

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
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      338
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      342
      num Events
      0
    term
    Acute coronary syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Device related sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Escherichia sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Gallbladder empyema
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      342
      num Events
      0
    term
    Gastroenteritis escherichia coli
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      342
      num Events
      0
    term
    Hepatic infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Infectious pleural effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      342
      num Events
      2
    term
    Klebsiella infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      342
      num Events
      2
    term
    Liver abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      342
      num Events
      0
    term
    Lower respiratory tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Angina pectoris

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
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      338
      num Events
      29
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      342
      num Events
      22
    term
    Urinary tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      338
      num Events
      41
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      342
      num Events
      44
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      338
      num Events
      35
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      342
      num Events
      39
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      338
      num Events
      12
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      342
      num Events
      22
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      338
      num Events
      12
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      342
      num Events
      43
    term
    Blood creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      338
      num Events
      17
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      342
      num Events
      27
    term
    Gamma-glutamyltransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      338
      num Events
      225
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      342
      num Events
      263
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      338
      num Events
      127
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      342
      num Events
      176
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      338
      num Events
      21
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      342
      num Events
      25
    term
    Weight decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      338
      num Events
      78
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      342
      num Events
      106
    term
    White blood cell count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      338
      num Events
      105
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      342
      num Events
      94
    term
    Decreased appetite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      338
      num Events
      41
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      342
      num Events
      29
    term
    Hypokalaemia
Complete source fields
description
There were 341 patients randomized to Durvalumab + Gemcitabine + Cisplatin and 344 patients randomized to Placebo + Gemcitabine + Cisplatin (Full Analysis Set). Five of these patients did not receive treatment (resulting in 338 in Durvalumab arm and 342 in Placebo arm for Safety Analysis Set). Hence, the Total numbers at risk for all-cause mortality is 341 (Durvalumab) and 344 (Placebo), while the Total number at Risk by any Serious/Other Adverse Event is 338 (Durvalumab) and 342 (Placebo).
event Groups
  1. deaths Num Affected
    308
    deaths Num At Risk
    341
    description
    Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
    id
    EG000
    other Num Affected
    326
    other Num At Risk
    338
    serious Num Affected
    168
    serious Num At Risk
    338
    title
    Durvalumab + Gemcitabine + Cisplatin
  2. deaths Num Affected
    326
    deaths Num At Risk
    344
    description
    Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
    id
    EG001
    other Num Affected
    330
    other Num At Risk
    342
    serious Num Affected
    152
    serious Num At Risk
    342
    title
    Placebo + Gemcitabine + Cisplatin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      338
      num Events
      29
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      342
      num Events
      22
    term
    Urinary tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      338
      num Events
      41
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      342
      num Events
      44
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      338
      num Events
      35
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      342
      num Events
      39
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      338
      num Events
      12
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      342
      num Events
      22
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      338
      num Events
      12
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      342
      num Events
      43
    term
    Blood creatinine increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      338
      num Events
      17
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      342
      num Events
      27
    term
    Gamma-glutamyltransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      338
      num Events
      225
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      342
      num Events
      263
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      338
      num Events
      127
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      342
      num Events
      176
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      338
      num Events
      21
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      342
      num Events
      25
    term
    Weight decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      338
      num Events
      78
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      342
      num Events
      106
    term
    White blood cell count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      338
      num Events
      105
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      342
      num Events
      94
    term
    Decreased appetite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      338
      num Events
      41
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      342
      num Events
      29
    term
    Hypokalaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      338
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      342
      num Events
      0
    term
    Acute coronary syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Device related sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Escherichia sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Gallbladder empyema
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      342
      num Events
      0
    term
    Gastroenteritis escherichia coli
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      342
      num Events
      0
    term
    Hepatic infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Infectious pleural effusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      342
      num Events
      2
    term
    Klebsiella infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      342
      num Events
      2
    term
    Liver abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      338
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      342
      num Events
      0
    term
    Lower respiratory tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      338
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      342
      num Events
      1
    term
    Angina pectoris
time Frame
Adverse events: from first dose of study medication up to 90 days after the last dose of study medication or until the initiation of the first subsequent therapy (whichever comes first), up to maximum of approximately 67 months. All-cause mortality (death due to any cause): from randomization up to analysis DCO (28 February 2025). Maximum timeframe of approximately 67 months.

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