TriangleNCT02663518 · OUTCOME
Part 4: 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
- Part 4: Day 1 of dosing up to 1 year of safety follow-up visit after the last dose (maximum treatment exposure for Part 4 was 667 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 event 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 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: TTI-621 2 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
| Group | Source count |
|---|---|
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 3 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 3 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg | 6 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg | 3 |
| Part 4: TTI-621 2 mg/kg | 12 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg | 4 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4: TTI-621 2 mg/kg | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: TTI-621 2 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 4
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- title
- TESAEs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 4
- 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 event 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 relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG000
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG001
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG002
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG003
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG004
- title
- Part 4: TTI-621 2 mg/kg
- description
- Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG005
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
- 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
- Part 4: Day 1 of dosing up to 1 year of safety follow-up visit after the last dose (maximum treatment exposure for Part 4 was 667 days)
- title
- Part 4: 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