TriangleNCT01121588 · OUTCOME
Number of Participants With All-Causality 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 the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)
What was measured
An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care activity of daily living (ADL); Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE.
Analysis population: All enrolled participants who received at least 1 dose of study treatment.
Groups in this outcome
ALCL Arm
In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
IMT Arm
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
Other Tumors
In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
| Group | Source count |
|---|---|
| ALCL Arm | 17 |
| IMT Arm | 9 |
| Other Tumors | 18 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 17 | Not reported | Not reported | Not reported | Not reported |
| IMT Arm | 9 | Not reported | Not reported | Not reported | Not reported |
| Other Tumors | 17 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 8 | Not reported | Not reported | Not reported | Not reported |
| IMT Arm | 4 | Not reported | Not reported | Not reported | Not reported |
| Other Tumors | 7 | Not reported | Not reported | Not reported | Not reported |
Maximum Grade 3 or 4 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 13 | Not reported | Not reported | Not reported | Not reported |
| IMT Arm | 7 | Not reported | Not reported | Not reported | Not reported |
| Other Tumors | 8 | Not reported | Not reported | Not reported | Not reported |
Maximum Grade 5 AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 2 | Not reported | Not reported | Not reported | Not reported |
| IMT Arm | 0 | Not reported | Not reported | Not reported | Not reported |
| Other Tumors | 4 | Not reported | Not reported | Not reported | Not reported |
AEs resulting in study treatment discontinuation (participant continued study)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 1 | Not reported | Not reported | Not reported | Not reported |
| IMT Arm | 0 | Not reported | Not reported | Not reported | Not reported |
| Other Tumors | 3 | Not reported | Not reported | Not reported | Not reported |
AEs resulting in dose reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 4 | Not reported | Not reported | Not reported | Not reported |
| IMT Arm | 1 | Not reported | Not reported | Not reported | Not reported |
| Other Tumors | 3 | Not reported | Not reported | Not reported | Not reported |
AEs resulting in temporary discontinuation of study treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | 8 | Not reported | Not reported | Not reported | Not reported |
| IMT Arm | 6 | Not reported | Not reported | Not reported | Not reported |
| Other Tumors | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 17
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 7
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 8
- title
- Maximum Grade 3 or 4 AEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- title
- Maximum Grade 5 AEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- title
- AEs resulting in study treatment discontinuation (participant continued study)
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- title
- AEs resulting in dose reduction
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 10
- title
- AEs resulting in temporary discontinuation of study treatment
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care activity of daily living (ADL); Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE.
- groups
- description
- In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- OG000
- title
- ALCL Arm
- description
- In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- OG001
- title
- IMT Arm
- description
- In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- OG002
- title
- Other Tumors
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All enrolled participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 444 weeks)
- title
- Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice