Trial Outcomes & Findings for Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice) (NCT NCT04155541)
NCT ID: NCT04155541
Last Updated: 2026-06-11
Results Overview
An adverse drug reaction (ADR) was a treatment-related adverse event (AE), and any untoward medical occurrence attributed to VIZIMPRO Tablets 15mg and/or 45mg in a participant who received this drug. A serious ADR was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect. Relatedness to this drug was assessed. This study focused on ILD, but an ADR other than ILD was also included in the analysis.
COMPLETED
40 participants
52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
2026-06-11
Participant Flow
Participant milestones
| Measure |
VIZIMPRO Tablets 15mg and/or 45mg (Dacomitinib) Single Arm
Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
VIZIMPRO Tablets 15mg and/or 45mg (Dacomitinib) Single Arm
Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
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|---|---|
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Overall Study
No informed consent for publication of study results
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2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
VIZIMPRO Tablets 15mg and 45mg (Dacomitinib)
n=38 Participants
Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
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|---|---|
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Age, Customized
<15 years
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0 participants
n=38 Participants
|
|
Age, Customized
≥15 and <65 years
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10 participants
n=38 Participants
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Age, Customized
≥65 years
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28 participants
n=38 Participants
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Sex: Female, Male
Female
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24 Participants
n=38 Participants
|
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Sex: Female, Male
Male
|
14 Participants
n=38 Participants
|
PRIMARY outcome
Timeframe: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).Population: The SAS (38 participants) comprised of participants who satisfied the inclusion criteria and had received VIZIMPRO Tablets 15mg and/or 45mg. Participants who did not provide informed consent were excluded.
An adverse drug reaction (ADR) was a treatment-related adverse event (AE), and any untoward medical occurrence attributed to VIZIMPRO Tablets 15mg and/or 45mg in a participant who received this drug. A serious ADR was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect. Relatedness to this drug was assessed. This study focused on ILD, but an ADR other than ILD was also included in the analysis.
Outcome measures
| Measure |
VIZIMPRO Tablets 15mg and 45mg (Dacomitinib)
n=38 Participants
Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
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|---|---|
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The Number and Percentage of Participants With Interstitial Lung Disease (ILD)
ILD
|
0 Participants
|
|
The Number and Percentage of Participants With Interstitial Lung Disease (ILD)
ADR
|
1 Participants
|
|
The Number and Percentage of Participants With Interstitial Lung Disease (ILD)
Serious ADR
|
1 Participants
|
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The Number and Percentage of Participants With Interstitial Lung Disease (ILD)
Rash
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1 Participants
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SECONDARY outcome
Timeframe: 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation.Population: The efficacy analysis set was defined as the population of participants in the SAS, excluding those who met any one of the following conditions: disease not under investigation or no efficacy information. Seven participants were excluded due to no efficacy information.
The response rate was calculated based on the best overall response as evaluated by the physician in accordance with the RECIST - Revised Version 1.1. The response rate was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR). In addition, the response rate and its two-sided 95% confidence interval (using exact method) were calculated. The participants not reported response were considered to have achieved a best overall response other than CR or PR.
Outcome measures
| Measure |
VIZIMPRO Tablets 15mg and 45mg (Dacomitinib)
n=31 Participants
Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
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|---|---|
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Assessment of Response Rate: Assess the Response Rate According to the "Response Evaluation Criteria in Solid Tumors Guidelines (RECIST) - Revised Version 1.1"
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12.9 Percentage of participants
Interval 3.6 to 29.8
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Adverse Events
VIZIMPRO Tablets 15mg and 45mg (Dacomitinib)
Serious adverse events
| Measure |
VIZIMPRO Tablets 15mg and 45mg (Dacomitinib)
n=38 participants at risk
Participants who received VIZIMPRO Tablets 15mg and/or 45mg as indicated in the approved local product document were observed for a period of 52 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
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|---|---|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
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2.6%
1/38 • 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
The frequency of AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study. This study focused on ILD, but AEs other than ILD were also included in the analysis.
|
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Cardiac disorders
Cardiac arrest
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2.6%
1/38 • 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
The frequency of AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study. This study focused on ILD, but AEs other than ILD were also included in the analysis.
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Skin and subcutaneous tissue disorders
Rash
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2.6%
1/38 • 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
The frequency of AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study. This study focused on ILD, but AEs other than ILD were also included in the analysis.
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Respiratory, thoracic and mediastinal disorders
ILD
|
0.00%
0/38 • 52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
The frequency of AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study. This study focused on ILD, but AEs other than ILD were also included in the analysis.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER