Table 2.
Treatment-emergent adverse events by preexisting condition.
| Adverse Event, % | Gastrointestinal |
Musculoskeletal |
Metabolic |
Vascular/Cardiac |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PAL + LET (n = 176) |
PBO + LET (n = 100) |
PAL + LET (n = 252) |
PBO + LET (n = 138) |
PAL + LET (n = 186) |
PBO + LET (n = 73) |
PAL + LET (n = 254) |
PBO + LET (n = 128) |
||||||||||
| All Grades | Grade 3/4 |
All Grades | Grade 3/4 |
All Grades | Grade 3/4 |
All Grades | Grade 3/4 |
All Grades | Grade 3/4 |
All Grades | Grade 3/4 |
All Grades | Grade 3/4 |
All Grades | Grade 3/4 |
||
| AE in ≥20 % of any group | |||||||||||||||||
| Neutropenia | 83.5 | 57.4/13.1 | 8.0 | 1.0/1.0 | 80.6 | 61.1/10.3 | 8.7 | 1.4/0.7 | 79.6 | 58.6/10.2 | 2.7 | 1.4/0 | 79.9 | 58.3/10.2 | 3.1 | 0.8/0 | |
| Infections | 65.9 | 10.8/1.7 | 47.0 | 3.0/0 | 68.3 | 7.1/0.8 | 48.6 | 2.2/0 | 67.7 | 8.1/1.6 | 50.7 | 5.5/0 | 63.8 | 8.7/1.2 | 46.1 | 3.9/0 | |
| Alopecia | 36.9 | N/A | 19.0 | N/A | 34.5 | N/A | 18.1 | N/A | 34.4 | N/A | 16.4 | N/A | 33.9 | N/A | 16.4 | N/A | |
| Arthralgia | 36.9 | 2.3/0 | 30.0 | 1.0/0 | 44.8 | 1.6/0 | 36.2 | 1.4/0 | 37.1 | 1.1/0 | 38.4 | 1.4/0 | 36.6 | 1.2/0 | 33.6 | 1.6/0 | |
| Leukopenia | 44.9 | 27.3/1.1 | 4.0 | 0/0 | 37.7 | 23.0/0.8 | 1.4 | 0/0 | 39.2 | 23.1/0.5 | 0 | 0 | 40.9 | 25.2/0.8 | 0.8 | 0/0 | |
| Fatigue | 44.3 | 4.0/0 | 29.0 | 1.0/0 | 50.4 | 3.2/0 | 28.3 | 2.2/0 | 39.8 | 2.7/0 | 31.5 | 2.7/0 | 41.7 | 3.1/0 | 29.7 | 2.3/0 | |
| Stomatitis | 37.5 | 1.1/0 | 19.0 | 0/0 | 32.5 | 1.6/0 | 18.8 | 0/0 | 28.0 | 1.1/0 | 15.1 | 0/0 | 30.7 | 1.2/0 | 13.3 | 0/0 | |
| Nausea | 40.9 | 0.6/0 | 38.0 | 3.0/0 | 45.6 | 0.4/0 | 30.4 | 1.4/0 | 43.0 | 0/0 | 34.2 | 2.7/0 | 36.6 | 0/0 | 25.8 | 1.6/0 | |
| Diarrhea | 36.9 | 2.3/0 | 26.0 | 2.0/0 | 35.3 | 2.0/0 | 26.8 | 1.4/0 | 34.4 | 1.6/0 | 26.0 | 2.7/0 | 31.1 | 2.0/0 | 20.3 | 0.8/0 | |
| Back pain | 31.3 | 3.4/0 | 22.0 | 0/0 | 30.6 | 2.8/0 | 27.5 | 0/0 | 23.7 | 1.1/0 | 26.0 | 0/0 | 24.8 | 2.0/0 | 22.7 | 0/0 | |
| Anemia | 34.7 | 6.8/0 | 10.0 | 1.0/0 | 25.8 | 7.5/0 | 8.7 | 0.7/0 | 30.1 | 8.6/0 | 8.2 | 0/0 | 29.5 | 6.7/0.4 | 5.5 | 0.8/0 | |
| Headache | 29.5 | 0/0 | 30.0 | 3.0/0 | 29.0 | 0.4/0 | 31.9 | 2.9/0 | 25.8 | 0/0 | 34.2 | 1.4/0 | 24.4 | 0.8/0 | 28.1 | 1.6/0 | |
| Hot flush | 28.4 | 0/0 | 38.0 | 0/0 | 26.6 | 0/0 | 36.2 | 0/0 | 25.3 | 0/0 | 35.6 | 0/0 | 22.4 | 0/0 | 30.5 | 0/0 | |
| Cough | 27.8 | 0.6/0 | 20.0 | 0/0 | 29.4 | 0.4/0 | 22.5 | 0/0 | 26.3 | 0/0 | 21.9 | 0/0 | 28.7 | 0/0 | 18.0 | 0/0 | |
| Abdominal pain | 19.9 | 3.4/0 | 7.0 | 0/0 | 16.7 | 2.0/10 | 8.0 | 0/0 | 14.0 | 0.5/0 | 9.6 | 0/0 | 15.7 | 1.2/0 | 4.7 | 0/0 | |
| Dizziness | 19.9 | 0.6/0 | 22.0 | 0/0 | 19.8 | 0.8/0 | 17.4 | 0/0 | 17.7 | 0/0 | 21.9 | 0/0 | 16.9 | 0.4/0 | 17.2 | 0/0 | |
| Viral upper RTI | 15.3 | 0/0 | 10.0 | 0/0 | 16.7 | 0/0 | 13.0 | 0/0 | 22.0 | 0/0 | 13.7 | 0/0 | 17.7 | 0/0 | 10.2 | 0/0 | |
| Asthenia | 23.3 | 5.1/0 | 10.0 | 0/0 | 14.3 | 2.4/0 | 11.6 | 0/0 | 17.2 | 1.6/0 | 13.7 | 0/0 | 16.9 | 3.9/0 | 11.7 | 0/0 | |
| Rash | 23.3 | 1.1/0 | 6.0 | 0/0 | 22.6 | 0.8/0 | 13.0 | 0.7/0 | 21.5 | 1.6/0 | 13.7 | 1.4/0 | 19.7 | 0.8/0 | 11.7 | 0.8/0 | |
| Constipation | 30.1 | 1.1/0 | 19.0 | 1.0/0 | 27.4 | 0.4/0 | 18.8 | 0.7/0 | 24.7 | 0/0 | 20.5 | 1.4/0 | 22.8 | 0/0 | 18.8 | 0.8/0 | |
| Vomiting | 25.6 | 2.3/0 | 24.0 | 2.0/0 | 22.6 | 0.8/0 | 19.6 | 1.4/0 | 22.6 | 0.5/0 | 20.5 | 2.7/0 | 17.7 | 0.4/0 | 18.0 | 1.6/0 | |
| Decreased appetite | 23.3 | 1.7/0 | 10.0 | 0/0 | 23.4 | 1.2/0 | 10.1 | 0/0 | 20.4 | 1.6/0 | 6.8 | 0/0 | 17.7 | 0.8/0 | 7.0 | 0/0 | |
| Dyspnea | 23.3 | 1.7/0 | 18.0 | 1.0/0 | 15.5 | 0.8/0 | 17.4 | 1.4/0 | 18.3 | 1.6/0 | 19.2 | 2.7/0 | 16.5 | 0.4/0 | 16.4 | 3.1/0 | |
| Pain in extremity | 23.9 | 0.6/0 | 21.0 | 2.0/0 | 23.8 | 0.4/0 | 22.5 | 0.7/0 | 18.8 | 0/0 | 17.8 | 1.4/0 | 20.1 | 0.4/0 | 21.1 | 1.6/0 | |
| AEs of special interest | |||||||||||||||||
| Febrile neutropenia | 2.8 | 2.3/0.6 | 0 | 0/0 | 2.8 | 2.4/0.4 | 0 | 0/0 | 2.2 | 1.6/0.5 | 0 | 0 | 3.1 | 2.4/0.8 | 0 | 0/0 | |
| Pulmonary embolism | 1.7 | 0.6/0.6 | 3.0 | 1.0/1.0 | 2.8 | 2.0/0.4 | 2.2 | 0.7/0.7 | 2.2 | 2.2/0 | 2.7 | 0/1.4 | 2.0 | 1.2/0.4 | 3.1 | 1.6/0.8 | |
| Hypertension | 12.5 | 8.0/0 | 8.0 | 7.0/0 | 9.5 | 5.6/0 | 10.1 | 7.2/0 | 10.8 | 7.0/0 | 11.0 | 9.6/0 | 10.2 | 5.5/0 | 12.5 | 10.2/0 | |
| Hyperglycemia | 5.1 | 0.6/0 | 9.0 | 1.0/0 | 2.8 | 0.8/0 | 6.5 | 1.4/0 | 2.7 | 1.6/0 | 9.6 | 2.7/0 | 5.5 | 1.2/0 | 7.8 | 0.8/0 | |
| Hypercholesterolemia | 0.6 | 0/0 | 3.0 | 0/0 | 1.2 | 0/0 | 1.4 | 0/0 | 1.6 | 0/0 | 1.4 | 0/0 | 1.6 | 0/0 | 2.3 | 0/0 | |
AE = adverse event; LET = letrozole; N/A = not applicable; PAL = palbociclib; PBO = placebo; RTI = respiratory tract infection.