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NCT01121393 · ADVERSE EVENTS

Adverse events

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC) · Source last updated 2018-12-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From first administration of study medication until 28 days after the last administration of study medication up to 374 weeks
Other-event reporting threshold
5%

The treated set (TS) included all randomised patients documented to have taken at least 1 dose of study medication. Analysis of Adverse Events (AEs) was based on the concept of treatment-emergent AEs. AEs with onset after the first administration of study drug and within 28 days after the last administration were considered to be on-treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Afatinib 40 Milligram (mg)

Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.

40 / 239236 / 23916 / 239
Gemcitabine / Cisplatin Chemotherapy

Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.

12 / 113112 / 1133 / 113

Group identifiers: EG000: Afatinib 40 Milligram (mg) · EG001: Gemcitabine / Cisplatin Chemotherapy

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      113
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Vertigo positional
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Upper gastrointestinal haemorrhage

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      113
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      113
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      113
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      113
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      113
    term
    Abdominal discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      113
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      212
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      113
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      113
    term
    Mouth ulceration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      113
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      113
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      113
    term
    Asthenia
Complete source fields
description
The treated set (TS) included all randomised patients documented to have taken at least 1 dose of study medication. Analysis of Adverse Events (AEs) was based on the concept of treatment-emergent AEs. AEs with onset after the first administration of study drug and within 28 days after the last administration were considered to be on-treatment.
event Groups
  1. deaths Num Affected
    16
    deaths Num At Risk
    239
    description
    Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
    id
    EG000
    other Num Affected
    236
    other Num At Risk
    239
    serious Num Affected
    40
    serious Num At Risk
    239
    title
    Afatinib 40 Milligram (mg)
  2. deaths Num Affected
    3
    deaths Num At Risk
    113
    description
    Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
    id
    EG001
    other Num Affected
    112
    other Num At Risk
    113
    serious Num Affected
    12
    serious Num At Risk
    113
    title
    Gemcitabine / Cisplatin Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      113
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      113
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      113
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      113
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      113
    term
    Abdominal discomfort
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      113
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      212
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      113
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      113
    term
    Mouth ulceration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      113
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      113
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      113
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      113
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      113
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Vertigo positional
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      239
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      113
    term
    Upper gastrointestinal haemorrhage
time Frame
From first administration of study medication until 28 days after the last administration of study medication up to 374 weeks

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