TriangleNCT04579679 · OUTCOME
Number of Patients With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months
What was measured
An AE is any untoward medical occurrence in a clinical study patient temporally associated with the use of a study drug, whether or not considered related to the drug. An SAE was an AE that resulted in any of the following outcomes: death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect or was any important medical event. TEAEs were defined as any AEs that started or worsened in severity on or after the first administration date of study drug and no later than 30 (+7) days after the last administration date of study drug or initiation of new anti-tumor therapy (whichever occurred first).
Analysis population: The safety analysis set included all patients who received at least 1 dose of surufatinib.
Groups in this outcome
Cohort A (NET, Lung)
Patients with NET of lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
Cohort B (NET, Small Bowel)
Patients with NET of small bowel origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
Cohort C (NET, Other)
Patients with NET of non-small bowel, non-pancreas, and non-lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
Cohort D (NET, Any)
Patients with NET of any origin received a single dose of drug cocktail (midazolam 2.5 mg, fexofenadine 30 mg and rosuvastatin 10 mg) on Day -2 followed by surufatinib 300 mg orally QD from C1D1 to C1D14. On C1D15, a single dose of surufatinib 300 mg and a single dose of drug cocktail as above was administered. Patients received surufatinib 300 mg orally QD from C1D16 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
| Group | Source count |
|---|---|
| Cohort A (NET, Lung) | 20 |
| Cohort B (NET, Small Bowel) | 32 |
| Cohort C (NET, Other) | 20 |
| Cohort D (NET, Any) | 6 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (NET, Lung) | 20 | Not reported | Not reported | Not reported | Not reported |
| Cohort B (NET, Small Bowel) | 32 | Not reported | Not reported | Not reported | Not reported |
| Cohort C (NET, Other) | 20 | Not reported | Not reported | Not reported | Not reported |
| Cohort D (NET, Any) | 6 | Not reported | Not reported | Not reported | Not reported |
TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (NET, Lung) | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort B (NET, Small Bowel) | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort C (NET, Other) | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort D (NET, Any) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 6
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 2
- title
- TESAEs
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- An AE is any untoward medical occurrence in a clinical study patient temporally associated with the use of a study drug, whether or not considered related to the drug. An SAE was an AE that resulted in any of the following outcomes: death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect or was any important medical event. TEAEs were defined as any AEs that started or worsened in severity on or after the first administration date of study drug and no later than 30 (+7) days after the last administration date of study drug or initiation of new anti-tumor therapy (whichever occurred first).
- groups
- description
- Patients with NET of lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
- id
- OG000
- title
- Cohort A (NET, Lung)
- description
- Patients with NET of small bowel origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
- id
- OG001
- title
- Cohort B (NET, Small Bowel)
- description
- Patients with NET of non-small bowel, non-pancreas, and non-lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
- id
- OG002
- title
- Cohort C (NET, Other)
- description
- Patients with NET of any origin received a single dose of drug cocktail (midazolam 2.5 mg, fexofenadine 30 mg and rosuvastatin 10 mg) on Day -2 followed by surufatinib 300 mg orally QD from C1D1 to C1D14. On C1D15, a single dose of surufatinib 300 mg and a single dose of drug cocktail as above was administered. Patients received surufatinib 300 mg orally QD from C1D16 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
- id
- OG003
- title
- Cohort D (NET, Any)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set included all patients who received at least 1 dose of surufatinib.
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months
- title
- Number of Patients With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice