Table 2.
Adverse events reported in ≥ 10% of patients in either group, by severity grade and type
| Adverse event | Palbociclib–Tamoxifen Group (n = 91) | Placebo–Tamoxifen Group (n = 93) | ||||
|---|---|---|---|---|---|---|
| Any Grade, n (%) | Grade 3, n (%) | Grade 4, n (%) | Any Grade, n (%) | Grade 3, n (%) | Grade 4, n (%) | |
| Any adverse events | 89 (97.8) | 69 (75.8) | 16 (17.6) | 81 (87.1) | 17 (18.3) | 2 (2.2) |
| Neutropeniaa | 83 (91.2) | 69 (75.8) | 12 (13.2) | 2 (2.2) | 1 (1.1) | 0 |
| Infectionsb | 45 (49.5) | 5 (5.5) | 1 (1.1) | 31 (33.3) | 4 (4.3) | 0 |
| Leukopeniac | 44 (48.4) | 26 (28.6) | 0 | 2 (2.2) | 0 | 0 |
| Stomatitisd | 34 (37.4) | 0 | 0 | 11 (11.8) | 0 | 0 |
| Thrombocytopeniae | 31 (34.1) | 3 (3.3) | 2 (2.2) | 2 (2.2) | 0 | 0 |
| Anemiaf | 28 (30.8) | 6 (6.6) | 0 | 9 (9.7) | 1 (1.1) | 0 |
| Rashg | 28 (30.8) | 0 | 0 | 7 (7.5) | 0 | 0 |
| Constipation | 20 (22.0) | 0 | 0 | 8 (8.6) | 1 (1.1) | 0 |
| Aspartate aminotransferase increased | 18 (19.8) | 3 (3.3) | 0 | 5 (5.4) | 1 (1.1) | 0 |
| Pyrexia | 18 (19.8) | 0 | 0 | 6 (6.5) | 0 | 0 |
| Alanine aminotransferase increased | 17 (18.7) | 4 (4.4) | 1 (1.1) | 6 (6.5) | 1 (1.1) | 0 |
| Back pain | 14 (15.4) | 1 (1.1) | 0 | 9 (9.7) | 1 (1.1) | 0 |
| Arthralgia | 13 (14.3) | 1 (1.1) | 0 | 15 (16.1) | 0 | 0 |
| Pruritus | 13 (14.3) | 0 | 0 | 1 (1.1) | 0 | 0 |
| Fatigue | 11 (12.1) | 0 | 0 | 9 (9.7) | 1 (1.1) | 0 |
| Nausea | 11 (12.1) | 0 | 0 | 11 (11.8) | 0 | 0 |
| Headache | 10 (11.0) | 0 | 0 | 7 (7.5) | 0 | 0 |
| Vomiting | 10 (11.0) | 1 (1.1) | 0 | 3 (3.2) | 1 (1.1) | 0 |
| Cough | 8 (8.8) | 0 | 0 | 15 (16.1) | 0 | 0 |
| Hot flash | 7 (7.7) | 0 | 0 | 13 (14.0) | 0 | 0 |
Adverse events were graded by CTCAE v4.0.
Patient with >1 adverse event within the same level of MedDRA term is counted as 1 at its maximum grade.
CTCAE common terminology criteria for adverse events, MedDRA medical dictionary for regulatory activities, PT preferred term.
aNeutropenia included events with the PTs of neutrophil count decreased and neutropenia.
bInfections included events with the PTs of nasopharyngitis, upper respiratory tract infection, cellulitis, cystitis, COVID-19, hordeolum, influenza, oral herpes, pneumonia, herpes zoster, tinea infection, COVID-19 pneumonia, conjunctivitis, dermatophytosis of nail, erysipelas, fungal skin infection, herpes simplex, impetigo, omphalitis, otitis externa, paronychia, parotitis, periodontitis, pharyngitis, pneumonia bacterial, septic shock, sinusitis, suspected COVID-19, urinary tract infection, brain abscess, bronchitis, denture stomatitis, gastroenteritis, helicobacter gastritis, herpes virus infection, myringitis, osteomyelitis, periorbital infection, pulpitis dental, sialadenitis, soft tissue infection, tinea pedis, tooth abscess, and vaginal infection.
cLeukopenia included events with the PT of white blood cell count decreased.
dStomatitis included events with the PTs of stomatitis, mucosal inflammation, oropharyngeal pain, cheilitis, glossitis, mouth ulceration, and glossodynia.
eThrombocytopenia included events with the PT of platelet count decreased.
fAnemia included events with the PTs of anemia and hemoglobin decreased.
gRash included events with the PTs of rash, rash maculo-papular, and rash erythematous.