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.

  1. Home
  2. About FDA
  3. FDA Organization
  4. Oncology Center of Excellence
  5. AURA3: Hair loss
  1. Section N/A

AURA3: Hair loss

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 HAIR LOSS?"

Patients scored the amount of their Hair Loss on a 5-point scale (Not at all, A little bit, Somewhat, Quite a bit, Very much)

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

Figure 1 shows the percentage of patients reporting how much Hair Loss they experienced at each time point. For example, at week 2, 13% of patients taking Tagrisso reported Hair Loss (A little bit). The range of patients who had any Hair Loss during the first 24 weeks of treatment with Tagrisso was between 7% - 13%. Click here for more information on how to read the graphs below.

Figure 1. Patient-Reported Hair Loss 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 amount of hair loss at each time point through the first 24 weeks of treatment. For example, at week 2, 13% of patients taking Tagrisso reported a little bit of hair loss.

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.


Worst Response Option for Hair Loss That Patients Reported During the First 24 Weeks on Treatment

Figure 2. Worst Patient-Reported Hair Loss During the First 24 Weeks on Treatment

Two pie charts, one for Tagrisso and the other for chemotherapy, summarizing the percentage of patients by worst reported hair loss during the first 24 weeks of the clinical trial. In the Tagrisso arm, Not at all (62%), A little bit (35%), Somewhat (2%), Quite a bit (1%) and Very much (0%). In the chemotherapy arm, Not at all (60%), A little bit (33%), Somewhat (5%), Quite a bit (0%) and Very much (2%).

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


Some Patients Did Not Report Hair Loss Before Treatment:

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

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

Two stacked bar charts, one for Tagrisso and the other for chemotherapy, which includes only those patients who had no hair loss before treatment. The bar charts show the proportion of patients reporting the amount of hair loss at each time point through 24 weeks. For example, at week 2, 8% of patients taking Tagrisso reported a little bit of hair loss.

All responses from patients who did not report Hair Loss 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.


Worst Response Option for Hair Loss That Patients Reported During the First 24 Weeks on Treatment, for Patients Who Did Not Have Hair Loss Before Treatment:

Figure 4. Worst Patient-Reported Hair Loss During the First 24 Weeks on Treatment: Patients Without Hair Loss Before Treatment

Two pie charts, one for Tagrisso and the other for chemotherapy, which includes only those patients who had no hair loss before treatment. The pie charts summarize the percentage of patients who reported any hair loss. In the Tagrisso arm, Not at all (76%), A little bit (22%), Somewhat (2%), Quite a bit (0%) and Very much (0%). In the chemotherapy arm, Not at all (65%), A little bit (26%), Somewhat (9%), Quite a bit (0%) and Very much (0%).

Patients who had no Hair Loss before treatment and at least one on-treatment Hair Loss score were included in the analysis. Tagrisso (N=64), Chemotherapy (N=35).

Back to Top