TriangleNCT05132582 · 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 study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
What was measured
An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both Serious AE (SAEs) and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant.
Analysis population: The SAS included all randomized participants who received at least one dose of study treatment (tucatinib or placebo, or trastuzumab or pertuzumab).
Groups in this outcome
Tucatinib + Trastuzumab + Pertuzumab
Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
Placebo + Trastuzumab + Pertuzumab
Participants with locally advanced HER2+/mBC were allocated to receive placebo PO BID, and trastuzumab 6 mg/kg IV or SC at a fixed dose of 600 mg, every 21 days, and pertuzumab 420 mg IV, every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
| Group | Source count |
|---|---|
| Tucatinib + Trastuzumab + Pertuzumab | 326 |
| Placebo + Trastuzumab + Pertuzumab | 324 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tucatinib + Trastuzumab + Pertuzumab | 323 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Trastuzumab + Pertuzumab | 313 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 323
- group Id
- OG001
- value
- 313
- denoms
- counts
- group Id
- OG000
- value
- 326
- group Id
- OG001
- value
- 324
- units
- Participants
- description
- An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. AEs included both Serious AE (SAEs) and all other AEs. An AE should be classified as a serious SAE if it meets one of the following criteria: fatal, life threatening, requires or prolongs hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant.
- groups
- description
- Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
- id
- OG000
- title
- Tucatinib + Trastuzumab + Pertuzumab
- description
- Participants with locally advanced HER2+/mBC were allocated to receive placebo PO BID, and trastuzumab 6 mg/kg IV or SC at a fixed dose of 600 mg, every 21 days, and pertuzumab 420 mg IV, every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
- id
- OG001
- title
- Placebo + Trastuzumab + Pertuzumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The SAS included all randomized participants who received at least one dose of study treatment (tucatinib or placebo, or trastuzumab or pertuzumab).
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to 42.3 months)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7
Preserved source evidence · Not medical advice