Purpose: Chemotherapy-induced gastrointestinal toxicity is a common adverse event during chemotherapeutic treatment.

Both drugs were well tolerated; the most common adverse event was headache.

Compliance and adverse event frequency were the same in both treatment groups.

The patient also had a biopsy-confirmed immune-related cutaneous adverse event during admission.

The most frequent adverse event was a reaction at the injection site.

There was no hair loss and no cardial or neurologic adverse event.

The deaths were not necessarily a result of the adverse event.

Treatment-emergent adverse event data were consistent with the known safety profile of lenalidomide.

Conclusion: The adverse event profile associated with ipilimumab was primarily immune-related.

Anaphylaxis or shock was cited in the FDA's adverse event reports 120 times.

We planned to collect adverse event data from the included studies.

The adverse event profile was similar for the 3 treatment groups.

Secondary safety analysis will involve the registration of any adverse event.

Headache was the most common adverse event across both dose groups.

No subject had an unexpected severe adverse event due to BT.

One subject was withdrawn due to an adverse event unrelated to study medications.