NCT04579679 · OUTCOME
Number of Patients With Potentially Clinically Significant Corrected QT Interval (QTc) During Treatment
Open-Label Surufatinib in European Patients With NET · Source last updated 2025-07-25
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
The QT interval data was corrected for heart rate using 2 correction methods (Fridericia - QTcF and Bazett - QTcB). The treatment period was defined as the period from first administration of study drug up 30 days after last administration. msec=milliseconds, IFB=increase from baseline.
Analysis population: The safety analysis set included all patients who received at least 1 dose of surufatinib. Only those patients with data collected are reported.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 19 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Reported measurements
QTcF: >450 msec to <=480 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 18 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcF: >480 msec to <=500 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 18 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcF: >500 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 18 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcF: IFB >30 msec to <=60 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 18 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcF: IFB >60 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 18 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcB: >450 msec to <=480 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 19 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcB: >480 msec to <=500 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 19 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcB: >500 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 19 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcB: IFB >30 msec to <=60 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 19 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
QTcB: IFB >60 msec
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 19 |
|---|
| Cohort B (NET, Small Bowel) | 31 |
|---|
| Cohort C (NET, Other) | 19 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcF: >450 msec to <=480 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcF: >480 msec to <=500 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcF: >500 msec
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcF: IFB >30 msec to <=60 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcF: IFB >60 msec
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcB: >450 msec to <=480 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcB: >480 msec to <=500 msec
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcB: >500 msec
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcB: IFB >30 msec to <=60 msec
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- QTcB: IFB >60 msec
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- The QT interval data was corrected for heart rate using 2 correction methods (Fridericia - QTcF and Bazett - QTcB). The treatment period was defined as the period from first administration of study drug up 30 days after last administration. msec=milliseconds, IFB=increase from baseline.
- 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. Only those patients with data collected are reported.
- 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 Potentially Clinically Significant Corrected QT Interval (QTc) During Treatment
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
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