NCT06390826 · 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 42 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. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Treatment (Sunitinib) | 5 / 9 | 6 / 9 | 7 / 10 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Lymphocyte count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- White blood cell decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Proteinuria
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 9
- term
- Hypertension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Thromboembolic event
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
- 3
- num At Risk
- 9
- 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
- 9
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Edema face
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 9
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Localized edema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Pain
- 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
- 9
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Dry skin
Complete source fields
- description
- All patients enrolled were included in the all-cause mortality analysis. Nine patients were included in the toxicity analysis (excluding one who did not receive treatment).
- event Groups
- deaths Num Affected
- 7
- deaths Num At Risk
- 10
- description
- Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
- id
- EG000
- other Num Affected
- 6
- other Num At Risk
- 9
- serious Num Affected
- 5
- serious Num At Risk
- 9
- title
- Treatment (Sunitinib)
- 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
- 3
- num At Risk
- 9
- 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
- 9
- term
- Palpitations
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Edema face
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 9
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Localized edema
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Pain
- 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
- 9
- term
- Alopecia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Dry skin
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 9
- term
- Lymphocyte count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Neutrophil count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Platelet count decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- White blood cell decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Renal and urinary disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Proteinuria
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 9
- term
- Hypertension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Vascular disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 9
- term
- Thromboembolic event
- time Frame
- Assessed every 42 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
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