NCT06360575 · ADVERSE EVENTS
Adverse events
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
- Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
- Other-event reporting threshold
- 5%
All patients enrolled were included in the all-cause mortality analysis. Eighteen patients were included in the toxicity analysis (excluding two who did not receive treatment).
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Treatment (Crizotinib) | 13 / 18 | 16 / 18 | 20 / 20 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 18
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Rash maculo-papular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Lung infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Urinary tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Infections and infestations - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 18
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 18
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Lymphocyte count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Generalized muscle weakness
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 18
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 18
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 18
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Pruritus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Rash maculo-papular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 18
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 18
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 18
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 18
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Gastrointestinal disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Urinary tract infection
Complete source fields
- description
- All patients enrolled were included in the all-cause mortality analysis. Eighteen patients were included in the toxicity analysis (excluding two who did not receive treatment).
- event Groups
- deaths Num Affected
- 20
- deaths Num At Risk
- 20
- description
- Patients receive crizotinib 250 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- EG000
- other Num Affected
- 16
- other Num At Risk
- 18
- serious Num Affected
- 13
- serious Num At Risk
- 18
- title
- Treatment (Crizotinib)
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 18
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 18
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 18
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Pruritus
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Rash maculo-papular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 18
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 18
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 18
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 18
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Gastrointestinal disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Urinary tract infection
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 18
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Rash maculo-papular
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Lung infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Urinary tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Infections and infestations - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 18
- term
- Alanine aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 18
- term
- Aspartate aminotransferase increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Lymphocyte count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Musculoskeletal and connective tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 18
- term
- Generalized muscle weakness
- time Frame
- Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
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