TriangleNCT03531840 · OUTCOME
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
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
- Adverse events were recorded from the study start date until prior to the study completion date, approximately 27 months and 11 days.
What was measured
Here is the count of participants with serious and non-serious adverse events 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.
Analysis population: Data is grouped as specified per protocol.
Groups in this outcome
Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
Comparison Group 2 Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations
Participants With no tumor tissue available for somatic mutation
Participants Not Classified Under Comparison Groups
Participants With no tumor tissue available for somatic mutation
| Group | Source count |
|---|---|
| Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 5 |
| Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 6 |
| Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | 8 |
| Participants Not Classified Under Comparison Groups | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes | 5 | Not reported | Not reported | Not reported | Not reported |
| Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations | 6 | Not reported | Not reported | Not reported | Not reported |
| Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations | 8 | Not reported | Not reported | Not reported | Not reported |
| Participants Not Classified Under Comparison Groups | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 4
- units
- Participants
- description
- Here is the count of participants with serious and non-serious adverse events 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.
- groups
- description
- Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
- id
- OG000
- title
- Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
- description
- Comparison Group 2 Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
- id
- OG001
- title
- Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
- description
- Participants With no tumor tissue available for somatic mutation
- id
- OG002
- title
- Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations
- description
- Participants With no tumor tissue available for somatic mutation
- id
- OG003
- title
- Participants Not Classified Under Comparison Groups
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Data is grouped as specified per protocol.
- reporting Status
- POSTED
- time Frame
- Adverse events were recorded from the study start date until prior to the study completion date, approximately 27 months and 11 days.
- title
- Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice