TriangleNCT04035486 · OUTCOME
Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only)
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 date to 28 days following last dose, up to 45 months
What was measured
Adverse events were summarized by maximum reported Common Terminology Criteria for Adverse Event (CTCAE) grade, version 5.0. Grade 1 (Mild): asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 (Severe or medically significant but not immediately life-threatening): hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 (Life-threatening consequences): urgent intervention indicated. Grade 5: Death related to AE. Includes adverse events with onset date on or after the date of first dose and up to and including 28 days following discontinuation of treatment but prior to the start of a new anti-cancer therapy.
Analysis population: Participants from the Safety Analysis Set, which includes all participants in the Safety Run-In Treatment Arms who received at least 1 dose of study treatment (osimertinib, cisplatin, carboplatin, or pemetrexed).
Groups in this outcome
Safety Run-In: AZD9291 + Carboplatin + Pemetrexed
Osimertinib (AZD9291) 80 mg once daily (QD) with Carboplatin (AUC of 5 mg/mL/min \[AUC5\]) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
Safety Run-In: AZD9291 + Cisplatin + Pemetrexed
Osimertinib (AZD9291) 80 mg once daily (QD) with Cisplatin (75 mg/m2) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
| Group | Source count |
|---|---|
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 15 |
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 15 |
Reported measurements
Source class 1
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 1 | Not reported | Not reported | Not reported | Not reported |
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 9 | Not reported | Not reported | Not reported | Not reported |
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 4 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 3 | Not reported | Not reported | Not reported | Not reported |
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 8 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 0 | Not reported | Not reported | Not reported | Not reported |
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 2 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 2 | Not reported | Not reported | Not reported | Not reported |
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 0 | Not reported | Not reported | Not reported | Not reported |
No Adverse Events Reported
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Safety Run-In: AZD9291 + Carboplatin + Pemetrexed | 0 | Not reported | Not reported | Not reported | Not reported |
| Safety Run-In: AZD9291 + Cisplatin + Pemetrexed | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Grade 1
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 4
- title
- Grade 2
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- No Adverse Events Reported
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- Adverse events were summarized by maximum reported Common Terminology Criteria for Adverse Event (CTCAE) grade, version 5.0. Grade 1 (Mild): asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 (Severe or medically significant but not immediately life-threatening): hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 (Life-threatening consequences): urgent intervention indicated. Grade 5: Death related to AE. Includes adverse events with onset date on or after the date of first dose and up to and including 28 days following discontinuation of treatment but prior to the start of a new anti-cancer therapy.
- groups
- description
- Osimertinib (AZD9291) 80 mg once daily (QD) with Carboplatin (AUC of 5 mg/mL/min \[AUC5\]) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
- id
- OG000
- title
- Safety Run-In: AZD9291 + Carboplatin + Pemetrexed
- description
- Osimertinib (AZD9291) 80 mg once daily (QD) with Cisplatin (75 mg/m2) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W
- id
- OG001
- title
- Safety Run-In: AZD9291 + Cisplatin + Pemetrexed
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants from the Safety Analysis Set, which includes all participants in the Safety Run-In Treatment Arms who received at least 1 dose of study treatment (osimertinib, cisplatin, carboplatin, or pemetrexed).
- reporting Status
- POSTED
- time Frame
- From first dose date to 28 days following last dose, up to 45 months
- title
- Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice