TriangleNCT04579757 · OUTCOME
Dose Escalation Phase: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
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 treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months
What was measured
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
Analysis population: The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
Groups in this outcome
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
| Group | Source count |
|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 6 |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 6 |
Reported measurements
Any TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 6 | Not reported | Not reported | Not reported | Not reported |
Any TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 3 | Not reported | Not reported | Not reported | Not reported |
Any TEAEs leading to surufatinib treatment discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 0 | Not reported | Not reported | Not reported | Not reported |
Any TEAEs leading to tislelizumab treatment discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- title
- Any TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- title
- Any TESAEs
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Any TEAEs leading to surufatinib treatment discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- title
- Any TEAEs leading to tislelizumab treatment discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment in humans, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
- groups
- description
- Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- id
- OG000
- title
- Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
- description
- Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
- id
- OG001
- title
- Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The SAS included all enrolled patients who received at least 1 dose of surufatinib or tislelizumab.
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months
- title
- Dose Escalation Phase: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice