Non-small Cell Lung Cancer
Conditions
Keywords
Safety, All cases surveillance in Japan, ALK-positive unresectable advanced and/or recurrent non-small cell lung cancer
Brief summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed description
All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
Interventions
XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)
Exclusion criteria
* Patients not administered XALKORI in spite of enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | 52 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) at 52 Weeks | 52 weeks | Clinical effectiveness of XALKORI Capsules was assessed as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or indeterminate by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XALKORI Capsules (Crizotinib) Participants who received XALKORI Capsules as indicated in the approved local product document were observed for a period of 52 weeks. The dosage can be adjusted as per physician's discretion. | 2,028 |
| Total | 2,028 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No Drug Administration | 1 |
Baseline characteristics
| Characteristic | XALKORI Capsules (Crizotinib) | — |
|---|---|---|
| Age, Customized <65 years | 1221 Participants | — |
| Age, Customized ≥65 years | 803 Participants | — |
| Age, Customized Unknown | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Female | 1087 Participants | — |
| Sex/Gender, Customized Male | 937 Participants | — |
| Sex/Gender, Customized Unknown | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 436 / 2,028 |
| other Total, other adverse events | 1,783 / 2,028 |
| serious Total, serious adverse events | 777 / 2,028 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician.
Time frame: 52 weeks
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received XALKORI Capsules at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XALKORI Capsules (Crizotinib) | Number of Participants With Adverse Drug Reactions | ADR | 1858 Participants |
| XALKORI Capsules (Crizotinib) | Number of Participants With Adverse Drug Reactions | Serious ADR | 518 Participants |
Secondary
Objective Response Rate (ORR) at 52 Weeks
Clinical effectiveness of XALKORI Capsules was assessed as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or indeterminate by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
Time frame: 52 weeks
Population: The efficacy analysis set (EAS) is comprised in the safety analysis set who had at least one measurable lesion and were evaluated for effectiveness. 1633 participants were included in the EAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XALKORI Capsules (Crizotinib) | Objective Response Rate (ORR) at 52 Weeks | 66.5 Percentage of participants |