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: Nausea
  1. Section N/A

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, how OFTEN did you have NAUSEA?"

Patients scored the frequency of their Nausea on a 5-point scale (Never, Rarely, Occasionally, Frequently, Almost Constantly)

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

Figure 1 shows the percentage of patients reporting how often they had Nausea at each time point. For example, at week 2, 20% of patients taking Tagrisso reported Nausea (ranging from Rarely to Frequently). The range of patients who had any Nausea during the first 24 weeks of treatment with Tagrisso was between 12% - 29%. Click here for more information on how to read the graphs below.

Figure 1. Patient-Reported Nausea 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 frequency of nausea at each time point through the first 24 weeks of treatment. For example, at week 2, 20% of patients taking Tagrisso reported nausea (ranging from Rarely to Frequently).

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 Nausea That Patients Reported During the First 24 Weeks on Treatment

Figure 2. Worst Patient-Reported Nausea 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 nausea during the first 24 weeks of the clinical trial. In the Tagrisso arm, Never (43%), Rarely (25%), Occasionally (21%), Frequently (6%) and Almost constantly (5%). In the chemotherapy arm, Never (13%), Rarely (25%), Occasionally (20%), Frequently (31%) and Almost constantly (11%).

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


Some Patients Did Not Report Nausea Before Treatment:

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

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

Two stacked bar charts, one for Tagrisso and the other for chemotherapy, which includes only those patients who had no nausea before treatment. The bar charts show the proportion of patients reporting frequency of nausea at each time point through 24 weeks. For example, at week 2, 7% of patients taking Tagrisso reported nausea (ranging from Rarely to Occasionally).

All responses from patients who did not report Nausea 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 Nausea That Patients Reported During the First 24 Weeks on Treatment, for Patients Who Did Not Have Nausea Before Treatment:

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

Two pie charts, one for Tagrisso and the other for chemotherapy, which includes only those patients who had no nausea before treatment. The pie charts summarize the percentage of patients by worst reported nausea. In the Tagrisso arm, Never (55%), Rarely (26%), Occasionally (17%), Frequently (0%) and Almost constantly (2%). In the chemotherapy arm, Never (20%), Rarely (27%), Occasionally (23%), Frequently (20%) and Almost constantly (10%).

Patients who had no Nausea before treatment and at least one on-treatment Nausea score were included in the analysis. Tagrisso (N=60), Chemotherapy (N=30).

Back to Top