TriangleNCT04685135 · OUTCOME
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 first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
What was measured
Treatment Emergent Adverse Events (TEAEs) are those that first occur or increase in severity on or after the first dose and not more than 28 days after the last dose, and prior to the initiation of subsequent systemic anti-cancer therapy. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Analysis population: Safety Population included all the participants who received at least one dose of the study drug. Docetaxel arm do not include adverse events after initiation of crossover Adagrasib treatment.
Groups in this outcome
Adagrasib
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).
Docetaxel
Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.
Crossover Adagrasib
Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID).
| Group | Source count |
|---|---|
| Adagrasib | 298 |
| Docetaxel | 140 |
| Crossover Adagrasib | 44 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adagrasib | 298 | Not reported | Not reported | Not reported | Not reported |
| Docetaxel | 138 | Not reported | Not reported | Not reported | Not reported |
| Crossover Adagrasib | 44 | Not reported | Not reported | Not reported | Not reported |
Any Treatment-Related TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adagrasib | 280 | Not reported | Not reported | Not reported | Not reported |
| Docetaxel | 121 | Not reported | Not reported | Not reported | Not reported |
| Crossover Adagrasib | 41 | Not reported | Not reported | Not reported | Not reported |
Any Treatment-Emergent SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adagrasib | 149 | Not reported | Not reported | Not reported | Not reported |
| Docetaxel | 50 | Not reported | Not reported | Not reported | Not reported |
| Crossover Adagrasib | 20 | Not reported | Not reported | Not reported | Not reported |
Any Treatment-Related Treatment-Emergent SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adagrasib | 62 | Not reported | Not reported | Not reported | Not reported |
| Docetaxel | 23 | Not reported | Not reported | Not reported | Not reported |
| Crossover Adagrasib | 7 | Not reported | Not reported | Not reported | Not reported |
Any TEAE Leading to Discontinuation of Treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adagrasib | 40 | Not reported | Not reported | Not reported | Not reported |
| Docetaxel | 25 | Not reported | Not reported | Not reported | Not reported |
| Crossover Adagrasib | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 298
- group Id
- OG001
- value
- 138
- group Id
- OG002
- value
- 44
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 280
- group Id
- OG001
- value
- 121
- group Id
- OG002
- value
- 41
- title
- Any Treatment-Related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 149
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 20
- title
- Any Treatment-Emergent SAE
- categories
- measurements
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 7
- title
- Any Treatment-Related Treatment-Emergent SAE
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 2
- title
- Any TEAE Leading to Discontinuation of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 298
- group Id
- OG001
- value
- 140
- group Id
- OG002
- value
- 44
- units
- Participants
- description
- Treatment Emergent Adverse Events (TEAEs) are those that first occur or increase in severity on or after the first dose and not more than 28 days after the last dose, and prior to the initiation of subsequent systemic anti-cancer therapy. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
- groups
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).
- id
- OG000
- title
- Adagrasib
- description
- Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.
- id
- OG001
- title
- Docetaxel
- description
- Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID).
- id
- OG002
- title
- Crossover Adagrasib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population included all the participants who received at least one dose of the study drug. Docetaxel arm do not include adverse events after initiation of crossover Adagrasib treatment.
- reporting Status
- POSTED
- time Frame
- From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice