TriangleNCT01154140 · OUTCOME
Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to follow up period (up to 72 months)
What was measured
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Analysis population: The safety analysis population included all randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.
Groups in this outcome
Crizotinib
Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
Chemotherapy
Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
| Group | Source count |
|---|---|
| Crizotinib | 171 |
| Chemotherapy | 169 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Crizotinib | 99.4 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 99.4 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Crizotinib | 41.5 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 29.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 99.4
- group Id
- OG001
- value
- 99.4
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 41.5
- group Id
- OG001
- value
- 29.0
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 171
- group Id
- OG001
- value
- 169
- units
- Participants
- description
- An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
- groups
- description
- Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
- id
- OG000
- title
- Crizotinib
- description
- Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
- id
- OG001
- title
- Chemotherapy
- param Type
- NUMBER
- population Description
- The safety analysis population included all randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.
- reporting Status
- POSTED
- time Frame
- Baseline up to follow up period (up to 72 months)
- title
- Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice