TriangleNCT04628780 · OUTCOME
Number of Participants With Maximum Grade 3 or 4 TEAEs
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 start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
What was measured
AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with Maximum Grade 3 or 4 TEAEs were reported.
Analysis population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Groups in this outcome
PF-07209960 1 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
PF-07209960 3 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
PF-07209960 10 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
PF-07209960 15 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
PF-07209960 20 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
PF-07209960 30 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
| Group | Source count |
|---|---|
| PF-07209960 1 mg SC | 4 |
| PF-07209960 3 mg SC | 4 |
| PF-07209960 10 mg SC | 4 |
| PF-07209960 15 mg SC | 3 |
| PF-07209960 20 mg SC | 16 |
| PF-07209960 30 mg SC | 6 |
Reported measurements
Participants with Maximum Grade 3 or 4 TEAEs (all-causality)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PF-07209960 1 mg SC | 3 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 3 mg SC | 2 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 10 mg SC | 1 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 15 mg SC | 1 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 20 mg SC | 11 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 30 mg SC | 5 | Not reported | Not reported | Not reported | Not reported |
Participants with Maximum Grade 3 or 4 TEAEs (treatment-related)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PF-07209960 1 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 3 mg SC | 0 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 10 mg SC | 1 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 15 mg SC | 2 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 20 mg SC | 8 | Not reported | Not reported | Not reported | Not reported |
| PF-07209960 30 mg SC | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 5
- title
- Participants with Maximum Grade 3 or 4 TEAEs (all-causality)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 5
- title
- Participants with Maximum Grade 3 or 4 TEAEs (treatment-related)
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with Maximum Grade 3 or 4 TEAEs were reported.
- groups
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
- id
- OG000
- title
- PF-07209960 1 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
- id
- OG001
- title
- PF-07209960 3 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
- id
- OG002
- title
- PF-07209960 10 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
- id
- OG003
- title
- PF-07209960 15 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
- id
- OG004
- title
- PF-07209960 20 mg SC
- description
- Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
- id
- OG005
- title
- PF-07209960 30 mg SC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
- title
- Number of Participants With Maximum Grade 3 or 4 TEAEs
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice