Grade 3-5 AEs during the follow-up period of the GALTON trial
| AE* . | During follow-up period, n (%) . | Overall, n (%)† . | ||||
|---|---|---|---|---|---|---|
| G-FC, n = 21 . | G-B, n = 20 . | All patients, N = 41 . | G-FC, n = 21 . | G-B, n = 20 . | All patients, N = 41 . | |
| Total no. of patients with at least 1 event | 2 (9.5) | 8 (40.0) | 10 (24.4) | 15 (71.4) | 18 (90.0) | 33 (80.5) |
| Febrile neutropenia | 2 (9.5) | 1 (5.0) | 3 (7.3) | 4 (19.0) | 2 (10.0) | 6 (14.6) |
| Neutropenia | 0 | 3 (15.0) | 3 (7.3) | 5 (23.8) | 10 (50.0) | 15 (36.6) |
| Leukopenia | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Thrombocytopenia | 0 | 1 (5.0) | 1 (2.4) | 3 (14.3) | 3 (15.0) | 6 (14.6) |
| Dyspnea | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Pneumonitis | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Pneumothorax | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Respiratory failure | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Small cell lung cancer | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Melanoma | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Chills | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Skin infection | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Syncope | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Intermittent claudication | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| AE* . | During follow-up period, n (%) . | Overall, n (%)† . | ||||
|---|---|---|---|---|---|---|
| G-FC, n = 21 . | G-B, n = 20 . | All patients, N = 41 . | G-FC, n = 21 . | G-B, n = 20 . | All patients, N = 41 . | |
| Total no. of patients with at least 1 event | 2 (9.5) | 8 (40.0) | 10 (24.4) | 15 (71.4) | 18 (90.0) | 33 (80.5) |
| Febrile neutropenia | 2 (9.5) | 1 (5.0) | 3 (7.3) | 4 (19.0) | 2 (10.0) | 6 (14.6) |
| Neutropenia | 0 | 3 (15.0) | 3 (7.3) | 5 (23.8) | 10 (50.0) | 15 (36.6) |
| Leukopenia | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Thrombocytopenia | 0 | 1 (5.0) | 1 (2.4) | 3 (14.3) | 3 (15.0) | 6 (14.6) |
| Dyspnea | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Pneumonitis | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Pneumothorax | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Respiratory failure | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Small cell lung cancer | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Melanoma | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Chills | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Skin infection | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Syncope | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
| Intermittent claudication | 0 | 1 (5.0) | 1 (2.4) | 0 | 1 (5.0) | 1 (2.4) |
The follow-up period was 36 months. One case each of myelodysplastic syndrome and of Richter transformation were noted after the planned follow-up of the trial.
Multiple occurrences of the same AE in an individual are only counted once.
Including only those grade 3-5 AEs with an incidence rate of at least 5%.