Criterion categories in 19 DLBCL RCTs
| Number of studies with criterion category n (%) . | Common criterion categories (present in >66% of RTs; n = 18 categories) . | Number of studies with criterion category n (%) . | Moderately common criterion categories (present in 33% to 66% of RCTs; n = 11 categories) . | Number of studies with criterion category n (%) . | Uncommon criterion categories (present in <33% of RTCs; n = 22 categories) . |
|---|---|---|---|---|---|
| 19 (100) | Age (y) | 11 (58) | HCV status | 6 (32) | Pulmonary function |
| 19 (100) | Histology | 11 (58) | Participation in other study | 6 (32) | Sex |
| 19 (100) | History of other malignancies | 10 (53) | Other neurologic pathology | 6 (32) | Recent surgical history |
| 19 (100) | Prior DLBCL treatment | 9 (47) | Hypersensitivity to study drugs | 5 (26) | Diabetes mellitus |
| 19 (100) | Renal function | 9 (47) | Other infectious disease status | 5 (26) | Patient compliance |
| 18 (95) | Hepatic function | 8 (42) | Imaging | 4 (21) | Adult patient under tutelage |
| 18 (95) | HIV status | 8 (42) | Minimum life expectancy | 4 (21) | Coagulopathy |
| 17 (89) | Cardiac function | 7 (37) | Contraindicated therapies | 4 (21) | Uncontrolled hypertension |
| 16 (84) | CNS involvement by lymphoma | 7 (37) | History of transformed lymphoma | 3 (16) | Hemoglobin (g/dL) |
| 16 (84) | Performance status | 7 (37) | Male reproductive concerns | 3 (16) | History of PTLD |
| 15 (79) | Contraindications to study therapy | 7 (37) | Psychiatric history | 3 (16) | Organ transplant history |
| 15 (79) | IPI score | 2 (11) | Bone marrow infiltration | ||
| 14 (74) | Female reproductive concerns | 2 (11) | Gastrointestinal function | ||
| 14 (74) | HBV status | 2 (11) | HTLV-1 status | ||
| 14 (74) | Other organ dysfunction | 1 (5) | CGA score | ||
| 14 (74) | Platelet count (platelets per µL) | 1 (5) | LDH level | ||
| 14 (74) | WBC count (cells per µL) | 1 (5) | Orthopedic history | ||
| 13 (68) | Ann Arbor stage | 1 (5) | Physical exam findings | ||
| 1 (5) | Rheumatologic disease | ||||
| 1 (5) | Substance use | ||||
| 1 (5) | Tumor invasion of major blood vessels | ||||
| 1 (5) | Vaccination history |
| Number of studies with criterion category n (%) . | Common criterion categories (present in >66% of RTs; n = 18 categories) . | Number of studies with criterion category n (%) . | Moderately common criterion categories (present in 33% to 66% of RCTs; n = 11 categories) . | Number of studies with criterion category n (%) . | Uncommon criterion categories (present in <33% of RTCs; n = 22 categories) . |
|---|---|---|---|---|---|
| 19 (100) | Age (y) | 11 (58) | HCV status | 6 (32) | Pulmonary function |
| 19 (100) | Histology | 11 (58) | Participation in other study | 6 (32) | Sex |
| 19 (100) | History of other malignancies | 10 (53) | Other neurologic pathology | 6 (32) | Recent surgical history |
| 19 (100) | Prior DLBCL treatment | 9 (47) | Hypersensitivity to study drugs | 5 (26) | Diabetes mellitus |
| 19 (100) | Renal function | 9 (47) | Other infectious disease status | 5 (26) | Patient compliance |
| 18 (95) | Hepatic function | 8 (42) | Imaging | 4 (21) | Adult patient under tutelage |
| 18 (95) | HIV status | 8 (42) | Minimum life expectancy | 4 (21) | Coagulopathy |
| 17 (89) | Cardiac function | 7 (37) | Contraindicated therapies | 4 (21) | Uncontrolled hypertension |
| 16 (84) | CNS involvement by lymphoma | 7 (37) | History of transformed lymphoma | 3 (16) | Hemoglobin (g/dL) |
| 16 (84) | Performance status | 7 (37) | Male reproductive concerns | 3 (16) | History of PTLD |
| 15 (79) | Contraindications to study therapy | 7 (37) | Psychiatric history | 3 (16) | Organ transplant history |
| 15 (79) | IPI score | 2 (11) | Bone marrow infiltration | ||
| 14 (74) | Female reproductive concerns | 2 (11) | Gastrointestinal function | ||
| 14 (74) | HBV status | 2 (11) | HTLV-1 status | ||
| 14 (74) | Other organ dysfunction | 1 (5) | CGA score | ||
| 14 (74) | Platelet count (platelets per µL) | 1 (5) | LDH level | ||
| 14 (74) | WBC count (cells per µL) | 1 (5) | Orthopedic history | ||
| 13 (68) | Ann Arbor stage | 1 (5) | Physical exam findings | ||
| 1 (5) | Rheumatologic disease | ||||
| 1 (5) | Substance use | ||||
| 1 (5) | Tumor invasion of major blood vessels | ||||
| 1 (5) | Vaccination history |
CGA, comprehensive geriatric assessment; CNS, central nervous system; HTLV-1, human T-lymphotropic virus 1; LDH, lactate dehydrogenase; PTLD, posttransplant lymphoproliferative disorder; WBC, white blood cell.