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NCT01423760 · ADVERSE EVENTS

Adverse events

Common Safety Follow-up Trial of Tecemotide (L-BLP25) · Source last updated 2016-10-06

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
Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
NSCLC

Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.

8 / 1212 / 12Not reported / Not reported
Multiple Myeloma

Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.

0 / 87 / 8Not reported / Not reported

Group identifiers: EG000: NSCLC · EG001: Multiple Myeloma

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
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Bronchopneumonia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Staphylococcal infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Urosepsis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Blood creatinine increased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Hyponatraemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Basal cell carcinoma
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Small cell lung cancer
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Squamous cell carcinoma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Acute kidney injury
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Haematuria

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Iron deficiency anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Angina pectoris
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Tachycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Deafness
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    term
    Cataract
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    term
    Dry eye
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    term
    Periorbital oedema
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    term
    Chronic gastritis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Diarrhoea
Complete source fields
event Groups
  1. description
    Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    8
    serious Num At Risk
    12
    title
    NSCLC
  2. description
    Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    0
    serious Num At Risk
    8
    title
    Multiple Myeloma
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Iron deficiency anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Angina pectoris
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Tachycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Deafness
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    term
    Cataract
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    term
    Dry eye
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    term
    Periorbital oedema
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    term
    Chronic gastritis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Diarrhoea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Bronchopneumonia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Sepsis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Staphylococcal infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Urosepsis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Blood creatinine increased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Hyponatraemia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Basal cell carcinoma
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Small cell lung cancer
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Squamous cell carcinoma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Acute kidney injury
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    term
    Haematuria
time Frame
Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years. AEs were reported only for Subjects who received tecemotide (L-BLP25) in feeder trial. No AEs were collected and reported for subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25)

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