TriangleNCT04432597 · OUTCOME
Phase I: Proportion of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- Not reported
- Time frame
- Date treatment consent signed to date of progression, an average of 6 months
What was measured
Phase I: proportion of participants that are hospitalized because of adverse events attributed to disease progression. Adverse events were assessed by the Common Terminology Criteria for Adverse Events(CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors(RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression.
Groups in this outcome
Phase I Cohort 1, Arm 1A, Dose Level 1
Phase I, Dose Level 1 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 1x10\^11 Viral Particles (VP).
Phase I Cohort 1A, Arm 1A, Dose Level 2
Phase I, Dose Level 2 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 5x10\^11 Viral Particles (VP).
Phase I Cohort 1, Arm 1B, Dose Level 2
Phase I in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1B: Combination: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A plus bintrafusp alfa 1200 mg. HPV vaccine at 5x10\^11 Viral Particles (VP).
| Group | Source count |
|---|---|
| Phase I Cohort 1, Arm 1A, Dose Level 1 | 3 |
| Phase I Cohort 1A, Arm 1A, Dose Level 2 | 3 |
| Phase I Cohort 1, Arm 1B, Dose Level 2 | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Cohort 1, Arm 1A, Dose Level 1 | 0.66 | Not reported | Not reported | Not reported | Not reported |
| Phase I Cohort 1A, Arm 1A, Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I Cohort 1, Arm 1B, Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.66
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- units
- Participants
- description
- Phase I: proportion of participants that are hospitalized because of adverse events attributed to disease progression. Adverse events were assessed by the Common Terminology Criteria for Adverse Events(CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors(RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression.
- groups
- description
- Phase I, Dose Level 1 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 1x10\^11 Viral Particles (VP).
- id
- OG000
- title
- Phase I Cohort 1, Arm 1A, Dose Level 1
- description
- Phase I, Dose Level 2 in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1A: Monotherapy HPV vaccine, Dose escalation. HPV vaccine at 5x10\^11 Viral Particles (VP).
- id
- OG001
- title
- Phase I Cohort 1A, Arm 1A, Dose Level 2
- description
- Phase I in recurrent/metastatic (R/M) Human Papillomavirus Vaccine (HPV) associated cancers (cohort 1). Arm 1B: Combination: HPV vaccine at recommended phase 2 dose (RP2D) as determined at completion of Arm 1A plus bintrafusp alfa 1200 mg. HPV vaccine at 5x10\^11 Viral Particles (VP).
- id
- OG002
- title
- Phase I Cohort 1, Arm 1B, Dose Level 2
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Date treatment consent signed to date of progression, an average of 6 months
- title
- Phase I: Proportion of Participants That Are Hospitalized Because of Adverse Events Attributed to Disease Progression
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice