TriangleNCT04256707 · OUTCOME
Combination Therapy (Arm C): Number of Participants With Treatment-emergent Adverse Events (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 study drug administration up to survival follow-up (up to 25 months)
What was measured
Adverse event (AE): Any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were any event that was not present prior to the initiation of study treatment, or any event already present that worsened in either intensity or frequency following exposure to study treatment.
Analysis population: Safety population: All participants who received at least 1 dose of study treatment in monotherapy or combination therapy periods.
Groups in this outcome
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)
Participants with colorectal cancer received selinexor 40 mg orally on Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5- fluorouracil (5-FU) 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)
Participants with colorectal cancer received selinexor 80 mg orally on Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5-FU 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
| Group | Source count |
|---|---|
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1) | 6 |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2) | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1) | 6 | Not reported | Not reported | Not reported | Not reported |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Adverse event (AE): Any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were any event that was not present prior to the initiation of study treatment, or any event already present that worsened in either intensity or frequency following exposure to study treatment.
- groups
- description
- Participants with colorectal cancer received selinexor 40 mg orally on Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5- fluorouracil (5-FU) 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
- id
- OG000
- title
- Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)
- description
- Participants with colorectal cancer received selinexor 80 mg orally on Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5-FU 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
- id
- OG001
- title
- Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population: All participants who received at least 1 dose of study treatment in monotherapy or combination therapy periods.
- reporting Status
- POSTED
- time Frame
- From start of study drug administration up to survival follow-up (up to 25 months)
- title
- Combination Therapy (Arm C): Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice