Nonhematologic AEs and hematologic laboratory data by chemotherapy regimen
| Characteristic . | Preselected for R-CHOP . | Preselected for R-CVP . | ||
|---|---|---|---|---|
| BR (n = 103), n (%) . | R-CHOP (n = 98), n (%) . | BR (n = 118), n (%) . | R-CVP (n = 116), n (%) . | |
| Nonhematologic AE (all grades) occurring in >10% of patients | ||||
| Nausea | 65 (63) | 57 (58) | 74 (63) | 45 (39)† |
| Vomiting | 30 (29) | 13 (13)† | 30 (25) | 15 (13)‡ |
| Constipation | 33 (32) | 39 (40) | 32 (27) | 51 (44)† |
| Diarrhea | 23 (22) | 21 (21) | 23 (19) | 29 (25) |
| Abdominal pain | 10 (10) | 11 (11) | 15 (13) | 16 (14) |
| Dyspepsia | 9 (9) | 13 (13) | 14 (12) | 13 (11) |
| Fatigue | 45 (44) | 45 (46) | 68 (58) | 62 (53) |
| Pyrexia | 18 (17) | 12 (12) | 19 (16) | 15 (13) |
| Chills | 11 (11) | 5 (5) | 14 (12) | 6 (5) |
| Edema peripheral | 5 (5) | 12 (12) | 14 (12) | 10 (9) |
| Mucosal inflammation | 3 (3) | 15 (15) | 9 (8) | 11 (9) |
| Drug hypersensitivity* | 18 (17) | 6 (6)‡ | 15 (13) | 4 (3)† |
| Infusion-related reaction | 23 (22) | 20 (20) | 29 (25) | 25 (22) |
| Infection* | 57 (55) | 56 (57) | 63 (53) | 58 (50) |
| Opportunistic infection* | 10 (10) | 7 (7) | 14 (12) | 10 (9) |
| Pneumonia/respiratory infection* | 19 (18) | 14 (14) | 17 (14) | 15 (13) |
| Decreased appetite | 24 (23) | 15 (15) | 18 (15) | 11 (9) |
| Arthralgia | 14 (14) | 8 (8) | 14 (12) | 23 (20) |
| Back pain | 7 (7) | 12 (12) | 16 (14) | 14 (12) |
| Myalgia | 6 (6) | 4 (4) | 7 (6) | 14 (12) |
| Musculoskeletal pain | 4 (4) | 4 (4) | 8 (7) | 13 (11) |
| Headache | 25 (24) | 19 (19) | 23 (19) | 26 (22) |
| Dysgeusia | 16 (16) | 13 (13) | 12 (10) | 12 (10) |
| Peripheral neuropathy/paresthesia* | 9 (9) | 43 (44)§ | 17 (14) | 55 (47)§ |
| Insomnia | 17 (17) | 24 (24) | 20 (17) | 23 (20) |
| Anxiety | 11 (11) | 10 (10) | 6 (5) | 8 (7) |
| Cough | 16 (16) | 20 (20) | 18 (15) | 14 (12) |
| Dyspnea | 8 (8) | 14 (14) | 9 (8) | 12 (10) |
| Rash/urticaria* | 21 (20) | 12 (12) | 28 (24) | 19 (16) |
| Alopecia | 4 (4) | 50 (51)║ | 4 (3) | 24 (21)║ |
| Nonhematologic AE (grade ≥3) occurring in ≥3% of patients | ||||
| Nausea | 3 (3) | 0 | 1 (<1) | 0 |
| Vomiting | 5 (5) | 0 | 2 (2) | 0 |
| Abdominal pain | 2 (2) | 3 (3) | 0 | 3 (3) |
| Drug hypersensitivity | 3 (3) | 0 | 2 (2) | 0 |
| Fatigue | 4 (4) | 2 (2) | 4 (3) | 1 (<1) |
| Pneumonia | 2 (2) | 0 | 5 (4) | 1 (<1) |
| Infusion-related reaction | 6 (6) | 4 (4) | 7 (6) | 4 (3) |
| Infection | 12 (12) | 5 (5) | 8 (7) | 8 (7) |
| Hyperglycemia | 0 | 2 (2) | 1 (<1) | 5 (4) |
| Back pain | 0 | 1 (1) | 0 | 4 (3) |
| Syncope | 1 (<1) | 0 | 0 | 3 (3) |
| Dyspnea | 2 (2) | 2 (2) | 3 (3) | 1 (<1) |
| Hematologic laboratory data (grade 3/4) | ||||
| White blood cell count | 33 (32) | 71 (72)§ | 51 (43) | 44 (38) |
| Absolute neutrophil count | 40 (39) | 85 (87)§ | 58 (49) | 65 (56) |
| Lymphocyte count | 63 (61) | 32 (33)§ | 74 (63) | 32 (28)§ |
| Hemoglobin | 0 | 3 (3) | 6 (5) | 6 (5) |
| Platelet count | 10 (10) | 12 (12) | 6 (5) | 2 (2) |
| Characteristic . | Preselected for R-CHOP . | Preselected for R-CVP . | ||
|---|---|---|---|---|
| BR (n = 103), n (%) . | R-CHOP (n = 98), n (%) . | BR (n = 118), n (%) . | R-CVP (n = 116), n (%) . | |
| Nonhematologic AE (all grades) occurring in >10% of patients | ||||
| Nausea | 65 (63) | 57 (58) | 74 (63) | 45 (39)† |
| Vomiting | 30 (29) | 13 (13)† | 30 (25) | 15 (13)‡ |
| Constipation | 33 (32) | 39 (40) | 32 (27) | 51 (44)† |
| Diarrhea | 23 (22) | 21 (21) | 23 (19) | 29 (25) |
| Abdominal pain | 10 (10) | 11 (11) | 15 (13) | 16 (14) |
| Dyspepsia | 9 (9) | 13 (13) | 14 (12) | 13 (11) |
| Fatigue | 45 (44) | 45 (46) | 68 (58) | 62 (53) |
| Pyrexia | 18 (17) | 12 (12) | 19 (16) | 15 (13) |
| Chills | 11 (11) | 5 (5) | 14 (12) | 6 (5) |
| Edema peripheral | 5 (5) | 12 (12) | 14 (12) | 10 (9) |
| Mucosal inflammation | 3 (3) | 15 (15) | 9 (8) | 11 (9) |
| Drug hypersensitivity* | 18 (17) | 6 (6)‡ | 15 (13) | 4 (3)† |
| Infusion-related reaction | 23 (22) | 20 (20) | 29 (25) | 25 (22) |
| Infection* | 57 (55) | 56 (57) | 63 (53) | 58 (50) |
| Opportunistic infection* | 10 (10) | 7 (7) | 14 (12) | 10 (9) |
| Pneumonia/respiratory infection* | 19 (18) | 14 (14) | 17 (14) | 15 (13) |
| Decreased appetite | 24 (23) | 15 (15) | 18 (15) | 11 (9) |
| Arthralgia | 14 (14) | 8 (8) | 14 (12) | 23 (20) |
| Back pain | 7 (7) | 12 (12) | 16 (14) | 14 (12) |
| Myalgia | 6 (6) | 4 (4) | 7 (6) | 14 (12) |
| Musculoskeletal pain | 4 (4) | 4 (4) | 8 (7) | 13 (11) |
| Headache | 25 (24) | 19 (19) | 23 (19) | 26 (22) |
| Dysgeusia | 16 (16) | 13 (13) | 12 (10) | 12 (10) |
| Peripheral neuropathy/paresthesia* | 9 (9) | 43 (44)§ | 17 (14) | 55 (47)§ |
| Insomnia | 17 (17) | 24 (24) | 20 (17) | 23 (20) |
| Anxiety | 11 (11) | 10 (10) | 6 (5) | 8 (7) |
| Cough | 16 (16) | 20 (20) | 18 (15) | 14 (12) |
| Dyspnea | 8 (8) | 14 (14) | 9 (8) | 12 (10) |
| Rash/urticaria* | 21 (20) | 12 (12) | 28 (24) | 19 (16) |
| Alopecia | 4 (4) | 50 (51)║ | 4 (3) | 24 (21)║ |
| Nonhematologic AE (grade ≥3) occurring in ≥3% of patients | ||||
| Nausea | 3 (3) | 0 | 1 (<1) | 0 |
| Vomiting | 5 (5) | 0 | 2 (2) | 0 |
| Abdominal pain | 2 (2) | 3 (3) | 0 | 3 (3) |
| Drug hypersensitivity | 3 (3) | 0 | 2 (2) | 0 |
| Fatigue | 4 (4) | 2 (2) | 4 (3) | 1 (<1) |
| Pneumonia | 2 (2) | 0 | 5 (4) | 1 (<1) |
| Infusion-related reaction | 6 (6) | 4 (4) | 7 (6) | 4 (3) |
| Infection | 12 (12) | 5 (5) | 8 (7) | 8 (7) |
| Hyperglycemia | 0 | 2 (2) | 1 (<1) | 5 (4) |
| Back pain | 0 | 1 (1) | 0 | 4 (3) |
| Syncope | 1 (<1) | 0 | 0 | 3 (3) |
| Dyspnea | 2 (2) | 2 (2) | 3 (3) | 1 (<1) |
| Hematologic laboratory data (grade 3/4) | ||||
| White blood cell count | 33 (32) | 71 (72)§ | 51 (43) | 44 (38) |
| Absolute neutrophil count | 40 (39) | 85 (87)§ | 58 (49) | 65 (56) |
| Lymphocyte count | 63 (61) | 32 (33)§ | 74 (63) | 32 (28)§ |
| Hemoglobin | 0 | 3 (3) | 6 (5) | 6 (5) |
| Platelet count | 10 (10) | 12 (12) | 6 (5) | 2 (2) |
Composite event composed of multiple preferred terms: drug hypersensitivity included cytokine-release syndrome, hypersensitivity, and anaphylactic shock; infections included candidiasis, catheter site infection, cellulitis, chronic sinusitis, diverticulitis, ear infection, febrile neutropenia, folliculitis, fungal skin infection, gastroenteritis, gastroenteritis viral, oral or genital herpes, herpes simplex or zoster, incision site infection, influenza, localized infection, oral candidiasis, postoperative wound infection, pyrexia, sinusitis, tooth abscess, tooth infection, urinary tract infection, and viral infection; opportunistic infections included candidiasis, Clostridium difficile colitis, cytomegalovirus, oral or genital herpes, herpes simplex or zoster, Pneumocystis jiroveci infection or pneumonia, and Pseudomonas infection; pneumonia/respiratory infection included bronchitis, lower respiratory tract infection, nasopharyngitis, pneumonia, and upper respiratory tract infection; peripheral neuropathy/paresthesia included peripheral neuropathy, sensory neuropathy, hypoesthesia, and paresthesia; and rash/urticaria included drug eruption; erythematous, exfoliative, generalized, heat, macular, maculopapular, and papular rashes; palmar–plantar erythrodysaesthesia syndrome; and urticaria.
P < .01, Pearson’s χ-square test.
P < .05, Pearson’s χ-square test.
P < .0001, Pearson’s χ-square test.
P < .0001, Fisher’s exact test.