TriangleNCT02663518 · OUTCOME
Part 1: Number of Participants 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
- Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days)
What was measured
An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (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: Safety population included all the participants who received at least one dose of study treatment.
Groups in this outcome
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
| Group | Source count |
|---|---|
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | 3 |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | 3 |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | 7 |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | 5 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
TESAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | 2 | 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
- 7
- group Id
- OG003
- value
- 5
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- title
- TESAEs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (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 advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG000
- title
- Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
- description
- Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG001
- title
- Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
- description
- Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG002
- title
- Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
- description
- Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG003
- title
- Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all the participants who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days)
- title
- Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice