TriangleNCT03427411 · OUTCOME
Percentage of Participants That Were 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
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 30 days from last treatment
What was measured
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 is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Analysis population: One participant enrolled in the refractory group was a screen failure and was not treated.
Groups in this outcome
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
| Group | Source count |
|---|---|
| Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 30 |
| Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 37.9 | Not reported | Not reported | Not reported | Not reported |
| Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 69.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 37.9
- group Id
- OG001
- value
- 69.2
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 26
- units
- Participants
- description
- 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 is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- groups
- description
- Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- id
- OG000
- title
- Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- description
- Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- id
- OG001
- title
- Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- param Type
- NUMBER
- population Description
- One participant enrolled in the refractory group was a screen failure and was not treated.
- reporting Status
- POSTED
- time Frame
- Up to 30 days from last treatment
- title
- Percentage of Participants That Were Hospitalized Because of Adverse Events Attributed to Disease Progression
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice