NCT02899195 · OUTCOME
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
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
- Up to 15 months from start of treatment
What was measured
Number of participants with abnormal laboratory values and/or adverse events related to treatment.
Analysis population: treated population
Groups in this outcome
Concurrent Durvalumab Then Maintenance Durvalumab
Pemetrexed/cisplatin will be given for up to six 3-week cycles with the addition of concurrent durvalumab every 3 weeks. Use of carboplatin in place of cisplatin will be permitted for patients who are ineligible for cisplatin due to impaired renal function at screening. For patients that receive cisplatin, carboplatin may also be substituted after Cycle 1 for cisplatin related toxicity at the investigator's discretion. Concurrent Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV will be administered before pemetrexed and cisplatin chemotherapy over approximately 60 minutes. Approximately 30 minutes after the durvalumab infusion is complete, pemetrexed 500 mg/m² IV will be administered over 10 minutes. Cisplatin 75 mg/m² IV over 2 hours will begin approximately 30 minutes after the end of pemetrexed administration. If carboplatin is substituted for cisplatin, carboplatin Area Under the Concentration-Time Curve (AUC) 5 will be infused over 30 minutes beginning approximately 15-30 minutes after the end of the pemetrexed administration. After completion of Cycle 6 of concurrent therapy, patients with stable or responding disease per modified RECIST for malignant mesothelioma will continue on single agent durvalumab every 3 weeks until progression. Maximum duration of durvalumab treatment is 12 months starting from Cycle 1 of concurrent treatment. Maintenance Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV over approximately 60 minutes.
| Group | Source count |
|---|---|
| Concurrent Durvalumab Then Maintenance Durvalumab | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Concurrent Durvalumab Then Maintenance Durvalumab | 36 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 36
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- description
- Number of participants with abnormal laboratory values and/or adverse events related to treatment.
- groups
- description
- Pemetrexed/cisplatin will be given for up to six 3-week cycles with the addition of concurrent durvalumab every 3 weeks. Use of carboplatin in place of cisplatin will be permitted for patients who are ineligible for cisplatin due to impaired renal function at screening. For patients that receive cisplatin, carboplatin may also be substituted after Cycle 1 for cisplatin related toxicity at the investigator's discretion. Concurrent Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV will be administered before pemetrexed and cisplatin chemotherapy over approximately 60 minutes. Approximately 30 minutes after the durvalumab infusion is complete, pemetrexed 500 mg/m² IV will be administered over 10 minutes. Cisplatin 75 mg/m² IV over 2 hours will begin approximately 30 minutes after the end of pemetrexed administration. If carboplatin is substituted for cisplatin, carboplatin Area Under the Concentration-Time Curve (AUC) 5 will be infused over 30 minutes beginning approximately 15-30 minutes after the end of the pemetrexed administration. After completion of Cycle 6 of concurrent therapy, patients with stable or responding disease per modified RECIST for malignant mesothelioma will continue on single agent durvalumab every 3 weeks until progression. Maximum duration of durvalumab treatment is 12 months starting from Cycle 1 of concurrent treatment. Maintenance Durvalumab: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV over approximately 60 minutes.
- id
- OG000
- title
- Concurrent Durvalumab Then Maintenance Durvalumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- treated population
- reporting Status
- POSTED
- time Frame
- Up to 15 months from start of treatment
- title
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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