How may I benefit from ADCETRIS?
AETHERA study design
AETHERA was a large clinical study of 329 people that compared the effectiveness and safety of ADCETRIS with placebo in patients with classical Hodgkin lymphoma that has a high risk of coming back or getting worse after a stem cell transplant.
- 165 people were assigned to receive ADCETRIS every 3 weeks for up to 16 cycles
- 164 people were assigned to receive placebo every 3 weeks for up to 16 cycles
High-risk classical Hodgkin lymphoma was defined in the study as when the first therapy does not work and the cancer does not respond to treatment, when disease returns within 12 months of the first treatment, or when disease returns more than 12 months after the first treatment, and there are signs of lymphoma in areas or organs outside the lymph nodes.
Researchers reviewed the progression-free survival results (primary endpoint) and the median time to cancer progression or death at approximately 2 years.
Progression-free survival results
More people treated with ADCETRIS did not experience cancer progression or death compared to placebo.
Median time to cancer progression or death
The most important serious safety information
Do not take ADCETRIS if you are receiving bleomycin due to pulmonary toxicity (serious lung problems).
Adcetris can cause other serious side effects including nerve damage, allergic and infusion reactions, blood problems, serious infections, tumor lysis syndrome (TLS), serious side effects for patients with severe kidney or moderate to severe liver disease, liver problems, lung problems, serious skin problems, gastrointestinal problems, high blood sugar (hypoglycemia) and fetal harm. Some of these cases resulted in death. Please see Important Safety Information below or Important Facts about ADCETRIS to learn more.
Most common side effects while taking ADCETRIS
The most common serious side effects that occurred in study patients were pneumonia (4%), fever (4%), vomiting (3%), nausea (2%), liver damage (2%), and PN (2%).
For more information on serious side effects and other side effects, please see the Important Safety Information at the bottom of this page and read the Important Facts about ADCETRIS, including BOXED WARNING.
Tell your doctor about any side effect concerns you have
Don’t stop, change, or delay your ADCETRIS treatment unless directed by your doctor. Your doctor may take additional steps to help manage side effects, including:
- Reducing your ADCETRIS dosage, or delaying your next dose, until symptoms improve
- Stopping ADCETRIS completely if side effects are severe or do not improve
For more information about understanding side effects, download a copy of the ADCETRIS side effects guide
Learn more about what you can expect before starting ADCETRIS treatment.
Glossary
Median: The middle number in a list of numbers.
Placebo: An inactive substance that does not contain medication. In clinical studies, it looks the same and is given the same way as the medication being tested.
Progression-free survival: The length of time during and after treatment that a person lives without their cancer getting worse.
Stem cell transplant: A procedure in which a patient receives healthy stem cells (blood-forming cells) to replace their own stem cells that have been destroyed by certain cancer treatments.