U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. FDA Organization
  4. Oncology Center of Excellence
  5. AURA3: Nail discoloration
  1. Section N/A

AURA3: Nail discoloration

Project Patient Voice is intended to be used with a healthcare professional when discussing the potential symptoms related to a cancer and cancer treatment. Do not rely on Project Patient Voice alone to make decisions about medical care. Do not use Project Patient Voice to substitute for advice from your health care professional. Conclusions about patient experiences with symptoms may be limited because not all symptoms may have been captured by the patient-reported questionnaire.

← Back to summary table

Download symptom data (XLSX, 24KB)

In AURA3 Study, Patients Were Asked: "In the last 7 days, did you have any CHANGE IN THE COLOR OF YOUR FINGERNAILS OR TOENAILS?"

Patients reported the occurrence of their Nail Discoloration on a 2-point scale (No, Yes)

Patient-Reported Nail Discoloration During the First 24 Weeks on Treatment for Patients Who Completed a Questionnaire:

Figure 1 shows the percentage of patients reporting if they had Nail Discoloration at each time point. For example, at week 2, 6% of patients taking Tagrisso reported Nail Discoloration. The range of patients who had any Nail Discoloration during the first 24 weeks of treatment with Tagrisso was between 1% - 16%. Click here for more information on how to read the graphs below.

Figure 1. Patient-Reported Nail Discoloration During the First 24 Weeks on Treatment

Two stacked bar charts, one for Tagrisso and the other for chemotherapy, showing proportion of patients reporting the occurrence of nail discoloration at each time point through the first 24 weeks of treatment. For example, at week 2, 6% of patients taking Tagrisso reported an occurrence of nail discoloration.

All responses from patients' experiences just before and up to week 24 on-treatment were included in the analysis. Some patients did not report their symptoms every week, therefore the number of patients may vary between weeks. Furthermore, not all patients remained on the treatment for 24 weeks (e.g., some stop treatment for worsening disease) which is a reason for the change in the number of patients over the course of treatment.

Any Nail Discoloration Occurrence That Patients Reported During the First 24 Weeks on Treatment

Figure 2. Any Patient-Reported Nail Discoloration During the First 24 Weeks on Treatment

Two pie charts, one for Tagrisso and the other for chemotherapy, summarizing the percentage of patients who reported any nail discoloration during the first 24 weeks of the clinical trial. In the Tagrisso arm, No (65%), and Yes (35%). In the chemotherapy arm, No (69%) and Yes (31%).

Patients with at least one on-treatment Nail Discoloration score were included in the analysis. Tagrisso (N=99), Chemotherapy (N=55).

Some Patients Did Not Report Nail Discoloration Before Treatment:

For patients that did not report Nail Discoloration before treatment, Figure 3 shows the percentage of patients reporting if they had Nail Discoloration between weeks 1 and 24.

Figure 3. Patient-Reported Nail Discoloration During the First 24 Weeks on Treatment: Patients Without Nail Discoloration Before Treatment

Two stacked bar charts, one for Tagrisso and the other for chemotherapy, which includes only those patients who had no nail discoloration before treatment. The bar charts show the proportion of patients reporting occurrence of nail discoloration at each time point through 24 weeks. For example, at week 2, 4% of patients taking Tagrisso reported an occurrence of nail discoloration.

All responses from patients who did not report Nail Discoloration before treatment were included in the analysis. Some patients did not report their symptoms every week, therefore the number of patients may vary between weeks. Furthermore, not all patients remained on the treatment for 24 weeks (e.g., some stop treatment for worsening disease) which is a reason for the change in the number of patients over the course of treatment.

Any Nail Discoloration Occurrence That Patients Reported During the First 24 Weeks on Treatment, for Patients Who Did Not Have Nail Discoloration Before Treatment:

Figure 4. Any Patient-Reported Nail Discoloration During the First 24 Weeks on Treatment: Patients Without Nail Discoloration Before Treatment

Two pie charts, one for Tagrisso and the other for chemotherapy, which includes only those patients who had no nail discoloration before treatment. The pie charts summarize the percentage of patients who reported any nail discoloration. In the Tagrisso arm, No (61%) and Yes (39%). In the chemotherapy arm, No (66%) and Yes (34%).

Patients who had no Nail Discoloration before treatment and at least one on-treatment Nail Discoloration score were included in the analysis. Tagrisso (N=75), Chemotherapy (N=41).

Back to Top