TriangleNCT04256707 · OUTCOME
Monotherapy: 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 4 months)
What was measured
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 can 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 included all participants who received at least 1 dose of study treatment in monotherapy or combination therapy periods.
Groups in this outcome
Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function
Participants with normal hepatic function received Tablet A (selinexor 5 × 20 mg tablets) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function
Participants with normal hepatic function received Tablet B (selinexor 1 × 100 mg tablet) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function
Participants with moderate hepatic function received Tablet A (selinexor 2 × 20 mg tablets) orally QW on Day 1 until PD, intolerability, or Investigator decision.
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function
Participants with severe hepatic function received Tablet A (selinexor 2 x 20 mg tablets) orally QW on Day 1 until PD, intolerability, or Investigator decision.
| Group | Source count |
|---|---|
| Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function | 11 |
| Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function | 11 |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function | 7 |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function | 9 | Not reported | Not reported | Not reported | Not reported |
| Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function | 11 | Not reported | Not reported | Not reported | Not reported |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function | 7 | Not reported | Not reported | Not reported | Not reported |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- 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 can 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 normal hepatic function received Tablet A (selinexor 5 × 20 mg tablets) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
- id
- OG000
- title
- Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function
- description
- Participants with normal hepatic function received Tablet B (selinexor 1 × 100 mg tablet) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
- id
- OG001
- title
- Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function
- description
- Participants with moderate hepatic function received Tablet A (selinexor 2 × 20 mg tablets) orally QW on Day 1 until PD, intolerability, or Investigator decision.
- id
- OG002
- title
- Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function
- description
- Participants with severe hepatic function received Tablet A (selinexor 2 x 20 mg tablets) orally QW on Day 1 until PD, intolerability, or Investigator decision.
- id
- OG003
- title
- Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included 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 4 months)
- title
- Monotherapy: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice