TriangleNCT01675765 · OUTCOME
Number of Subjects Reporting Adverse Events
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 study dose until 28 days after the final dose (an average of 44 weeks)
What was measured
Count of subjects with incidences of adverse events.
Analysis population: Safety Analysis Set (all participants who received \>= 1 dose of study treatment)
Groups in this outcome
Immunotherapy Plus Chemotherapy
Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
Immunotherapy With Cyclophosphamide Plus Chemotherapy
Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
| Group | Source count |
|---|---|
| Immunotherapy Plus Chemotherapy | 38 |
| Immunotherapy With Cyclophosphamide Plus Chemotherapy | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Immunotherapy Plus Chemotherapy | 38 | Not reported | Not reported | Not reported | Not reported |
| Immunotherapy With Cyclophosphamide Plus Chemotherapy | 22 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 22
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- Count of subjects with incidences of adverse events.
- groups
- description
- Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
- id
- OG000
- title
- Immunotherapy Plus Chemotherapy
- description
- Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
- id
- OG001
- title
- Immunotherapy With Cyclophosphamide Plus Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set (all participants who received \>= 1 dose of study treatment)
- reporting Status
- POSTED
- time Frame
- From first study dose until 28 days after the final dose (an average of 44 weeks)
- title
- Number of Subjects Reporting Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice