TriangleNCT05386550 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-related 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
- Time from randomization up to 22.7 months
What was measured
Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: events that start with onset or worsening (seriousness or severity) dates occurring within the on-treatment periods. TEAEs included both serious and non-serious TEAEs. Related TEAEs are events with relationship missing or related.
Analysis population: SAF included all participants, who were administered any dose of any study intervention. One participant who was randomized to the Placebo + IMRT group but was incorrectly administered a dose of Xevinapant was analyzed in the Xevinapant + IMRT group.
Groups in this outcome
Xevinapant +IMRT
Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
Placebo +IMRT
Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
| Group | Source count |
|---|---|
| Xevinapant +IMRT | 82 |
| Placebo +IMRT | 83 |
Reported measurements
TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Xevinapant +IMRT | 81 | Not reported | Not reported | Not reported | Not reported |
| Placebo +IMRT | 81 | Not reported | Not reported | Not reported | Not reported |
Related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Xevinapant +IMRT | 80 | Not reported | Not reported | Not reported | Not reported |
| Placebo +IMRT | 79 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 81
- title
- TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 79
- title
- Related TEAEs
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 83
- units
- Participants
- description
- Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: events that start with onset or worsening (seriousness or severity) dates occurring within the on-treatment periods. TEAEs included both serious and non-serious TEAEs. Related TEAEs are events with relationship missing or related.
- groups
- description
- Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
- id
- OG000
- title
- Xevinapant +IMRT
- description
- Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
- id
- OG001
- title
- Placebo +IMRT
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- SAF included all participants, who were administered any dose of any study intervention. One participant who was randomized to the Placebo + IMRT group but was incorrectly administered a dose of Xevinapant was analyzed in the Xevinapant + IMRT group.
- reporting Status
- POSTED
- time Frame
- Time from randomization up to 22.7 months
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-related TEAEs
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice