Table 4 Adverse drug reaction profile for FTD/TPI in German Compassionate-Use-Program (CUP) and the RECOURSE trial
Adverse Events (AE) | FTD/TPI (n = 226 patients) | RECOURSE - FTD/TPIa (n = 533 patients) | |||
|---|---|---|---|---|---|
Total number | Related | Non-related | Total number Any Grade | Grade ≥ 3 | |
Any adverse event | 253 | 138 | 115 | 524 | 370 |
Any serious adverse event (SAE) - no. (%) | 124c (55) | 74d (33) | 50e (22) | 158 (30) | n.a |
Most common AEsb - no. (%) | Total number Any Grade | Serious | Non-serious | Total number Any Grade | Grade ≥ 3 |
Nausea | 15 (5.9) | 5 (2.0) | 10 (4.0) | 258 (48) | 10 (2) |
Diarrhea | 11 (4.3) | 5 (2.0) | 6 (2.4) | 170 (32) | 16 (3) |
Fatigue | 9 (3.6) | 5 (2.0) | 4 (1.6) | 188 (35) | 21 (4) |
Influenza like illness/Pyrexia/Chills/Fever | 9 (3.6) | 3 (1.2) | 6 (2.4) | 99 (19) | 7 (1) |
General physical health deterioration/Asthenia | 8 (3.2) | 5 (2.0) | 3 (1.2) | 97 (18) | 18 (3) |
Vomiting | 7 (2.8) | 3 (1.2) | 4 (1.6) | 148 (28) | 11 (2) |
Abdominal pain | 7 (2.8) | 4 (1.6) | 3 (1.2) | 113 (21) | 13 (2) |
Decreased appetite | 3 (1.2) | 1 (< 1) | 2 (< 1) | n.a | n.a |
Urinary tract infection/Urosepis | 3 (1.2) | 2 (< 1) | 1 (< 1) | n.a | n.a |
Constipation/subileus | 3 (1.2) | 2 (< 1) | 1 (< 1) | n.a | n.a |
Condition aggravated | 3 (1.2) | 3 (1.2) | 0 (0) | n.a | n.a |
Alopecia | 2 (< 1) | 0 (0) | 2 (< 1) | n.a | n.a |
Musculoskeletal pain | 2 (< 1) | 1 (< 1) | 1 (< 1) | n.a | n.a |
Events associated with fluoropyrimidine treatment | |||||
Stomatitis/Oesophagitis | 2 (< 1) | 1 (< 1) | 1 (< 1) | 43 (8) | 2 (< 1) |
Mucosal inflammation | 1 (< 1) | 0 (0) | 1 (< 1) | n.a | n.a |
Oesophageal candidiasis | 1 (< 1) | 0 (0) | 1 (< 1) | n.a | n.a |
Hand-foot syndrome | 0 (0) | 0 (0) | 0 (0) | 12 (2) | 0 (0) |
Febrile neutropenia | 1 (< 1) | 1 (< 1) | 0 (0) | 20 (4) | 20 (4) |
Laboratory abnormalities no. /no./total no. (%) | |||||
Leukopenia | 25 (9.9) | 13 (5.1) | 12 (4.7) | 407/528 (67) | 113/528 (21) |
Neutropenia | 19 (7.5) | 9 (3.6) | 10 (4.0) | 353/528 (67) | 200/528 (38) |
Anemia | 15 (5.9) | 7 (2.8) | 8 (3.2) | 404/528 (77) | 96/528 (18) |
Thrombocytopenia | 7 (2.8) | 4 (1.6) | 3 (1.2) | 223/528 (42) | 27/28 (5) |
Increase in total bilirubin | 4 (1.6) | 3 (1.2) | 1 (< 1) | 189/526 (36) | 45/526 (9) |
Renal failure/Increase in creatinine level | 2 (< 1) | 1 (< 1) | 1 (< 1) | 71/527 (13) | 5/527 (< 1) |
Increase in alanine aminotransferase level | 0 (0) | 0 (0) | 0 (0) | 126/526 (24) | 10/256 (2) |
Increase in aspartate aminotransferase level | 1 (< 1) | 0 (0) | 1 (< 1) | 155/524 (30) | 23/524 (4) |
Increase alkaline phosphatase level | 1 (< 1) | 0 (0) | 1 (< 1) | 205/526 (39) | 42/526 (8) |