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AURA3: Constipation

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.

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In AURA3 Study, Patients Were Asked: "In the last 7 days, what was the SEVERITY of your CONSTIPATION at its WORST?"

Patients scored the severity of their Constipation on a 5-point scale (None, Mild, Moderate, Severe, Very Severe)

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

Figure 1 shows the percentage of patients reporting the severity of their Constipation at each time point. For example, at week 2, 30% of patients taking Tagrisso reported Constipation (ranging from Mild to Severe). The range of patients who had any Constipation during treatment with Tagrisso was between 20% - 33%. Click here for more information on how to read the graphs below.

Figure 1. Patient-Reported Constipation 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 severity of constipation at each time point through the first 24 weeks of treatment. For example, at week 2, 30% of patients taking Tagrisso reported constipation (ranging from mild to severe).

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 Constipation That Patients Reported During the First 24 Weeks on Treatment

Figure 2. Worst Patient-Reported Constipation 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 constipation during the first 24 weeks of the clinical trial. In the Tagrisso arm, None (34%), Mild (42%), Moderate (11%), Severe (9%) and Very severe (4%). In the chemotherapy arm, None (5%), Mild (31%), Moderate (24%), Severe (25%) and Very severe (15%).

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


Some Patients Did Not Report Constipation Before Treatment:

For patients that did not report Constipation before treatment, Figure 3 shows the percentage of patients reporting the severity of their Constipation between weeks 1 and 24.

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

Two stacked bar charts, one for Tagrisso and the other for chemotherapy, which includes only those patients who had no constipation before treatment. The bar charts show the proportion of patients reporting severity of constipation at each time point through 24 weeks. For example, at week 2, 16% of patients taking Tagrisso reported constipation (ranging from mild to severe).

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

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

Two pie charts, one for Tagrisso and the other for chemotherapy, which includes only those patients who had no constipation before treatment. The pie charts summarize the percentage of patients by worst reported constipation. In the Tagrisso arm, None (54%), Mild (33%), Moderate (9%), Severe (4%), and Very severe (0%). In the chemotherapy arm, None (8%), Mild (29%), Moderate (29%), Severe (25%) and Very severe (9%).

Patients who had no Constipation before treatment and at least one on-treatment Constipation score were included in the analysis. Tagrisso (N=46), Chemotherapy (N=24).

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