TriangleNCT02663518 · OUTCOME
Part 2 and 3: Number of Participants With TEAEs and 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
- Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)
What was measured
An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
Analysis population: Analysis population included all the participants who received at least one dose of study treatment.
Groups in this outcome
Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
| Group | Source count |
|---|---|
| Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 107 |
| Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 42 |
| Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 11 |
| Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 40 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 103 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 40 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 11 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 37 | Not reported | Not reported | Not reported | Not reported |
TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 43 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy | 15 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination | 13 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 37
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 13
- title
- TESAEs
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 40
- units
- Participants
- description
- An AE was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state.
- groups
- description
- Participants with a broader variety of hematologic malignancies and selected solid tumors, received a 0.2 mg/kg/week TTI-621 infusion until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG000
- title
- Part 2: Ontorpacept (PF-07901800/TTI-621) Monotherapy
- description
- Participants with CTCL and PTCL, received a 0.2 mg/kg/week TTI-621 infusion. Initial 2 weeks of 0.2 mg/kg treatment followed by intraparticipant dose intensification at an increment of 0.1 mg/kg per week up to 0.5 mg/kg within 5-8 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG001
- title
- Part 3: Ontorpacept (PF-07901800/TTI-621) Monotherapy
- description
- Participants with cHL received 0.1 mg/kg/week TTI-621 infusion along with 3 mg/kg nivolumab given every 2 weeks or a fixed dose per current FDA approved package insert for cHL. If required dose of TTI-621 could be increased up to 0.5 mg/kg/week. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
- id
- OG002
- title
- Part 2: Ontorpacept (PF-07901800/TTI-621)+ Nivolumab Combination
- description
- Participants with CD20-positive malignancies received 0.1 mg/kg/week TTI-621 infusion along with 375 mg/m\^2 rituximab given weekly (1 cycle) for up to 8 cycles according to the institutional standard of care. Participants received TTI-621 monotherapy upon completion of combination partner regimen/unacceptable toxicity to the combination regimen.
- id
- OG003
- title
- Part 2: Ontorpacept (PF-07901800/TTI-621) + Rituximab Combination
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Analysis population included all the participants who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 2 was 1793 days and for Part 3 was 938 days)
- title
- Part 2 and 3: Number of Participants With TEAEs and TESAEs
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice