TEAEs, regardless of relationship to study drug
| Adverse event . | Any grade (%) . | Grade III/IV (%) . |
|---|---|---|
| Hematological TEAEs | ||
| Anemia | 8% | 2% |
| Neutropenia | 7% | 6% |
| Thrombocytopenia | 15% | 5% |
| Nonhematological TEAE, frequency of >10% | ||
| Infection | 30% | 3%‡ |
| Fatigue | 26% | |
| Upper respiratory infection | 24% | |
| Increased lipase | 21% | 10% |
| Skin disorders, including rash | 20% | |
| Headache | 19% | |
| Abdominal pain | 18% | 2% |
| Nausea | 17% | |
| Diarrhea | 17% | |
| Musculoskeletal disorder | 16% | |
| Other | 16% | |
| Gastrointestinal | 13% | 1% |
| Back pain | 11% | 1% |
| Arthralgia | 10% | |
| Selected nonhematological TEAEs, frequency of <10% | ||
| Hypertension∗ | 22% | 3% |
| Increased amylase | 7% | 2% |
| Increased alkaline phosphatase | 5% | |
| Increased AST | 6% | 1% |
| Increased ALT | 4% | 1% |
| Increased bilirubin | 3% | |
| Stroke† | 1% | 1% |
| Adverse event . | Any grade (%) . | Grade III/IV (%) . |
|---|---|---|
| Hematological TEAEs | ||
| Anemia | 8% | 2% |
| Neutropenia | 7% | 6% |
| Thrombocytopenia | 15% | 5% |
| Nonhematological TEAE, frequency of >10% | ||
| Infection | 30% | 3%‡ |
| Fatigue | 26% | |
| Upper respiratory infection | 24% | |
| Increased lipase | 21% | 10% |
| Skin disorders, including rash | 20% | |
| Headache | 19% | |
| Abdominal pain | 18% | 2% |
| Nausea | 17% | |
| Diarrhea | 17% | |
| Musculoskeletal disorder | 16% | |
| Other | 16% | |
| Gastrointestinal | 13% | 1% |
| Back pain | 11% | 1% |
| Arthralgia | 10% | |
| Selected nonhematological TEAEs, frequency of <10% | ||
| Hypertension∗ | 22% | 3% |
| Increased amylase | 7% | 2% |
| Increased alkaline phosphatase | 5% | |
| Increased AST | 6% | 1% |
| Increased ALT | 4% | 1% |
| Increased bilirubin | 3% | |
| Stroke† | 1% | 1% |
Listed are hematological events, nonhematological events that occurred at >10% frequency, as well as selected events of interest at <10% frequency.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, common terminology criteria for adverse events; TEAE, treatment-emergent adverse events; TIA, transient ischemic attack.
Treatment-emergent hypertension in this table is defined as any 2 consecutive measurements meeting the CTCAE criteria, without a prior history of hypertension at study entry. The relevant parameters are: SBP of ≥140 to 159 mmHg and/or DBP of ≥90 to 99 mmHg for all grades, and SBP of ≥160 mmHg and/or DBP of ≥100 mmHg for grade ≥3. Refer to text for further information.
A 73-year-old woman with preexisting type 2 diabetes, hypertension, and high body mass index had a lacunar infarct 20 months into treatment presenting as a TIA, with a second TIA affecting the same territory 28 months into treatment. There was complete neurological recovery after each episode. No other treatment emergent arterial occlusive event was reported.
The 3 grade 3 infective episodes were hospitalizations in 3 patients for pneumonia, skin infection from cat scratch, and septic arthritis.