Clinical details on TEAEs of BTH over the entire trial
| Participant . | Reported BTH event . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase (start day/end day)∗ . | Treatment arm (dose) . | C5 inhibitor (dose) . | Severity grade† . | Hb before BTH event, g/dL . | Hb during BTH event, g/dL . | Hb after BTH event, g/dL . | LDH before BTH event, U/L . | LDH at time of BTH event, U/L . | Related to danicopan . | Outcome . | Need for transfusion . | Concurrent AEs . | |
| Male, 54 y | TP2 (127/156) | Danicopan-danicopan (200 mg) | Ravulizumab (3300 mg) | 3 | 11.0 | 7.3 | 13.6 | 447.0 | 336.0 | No | No dose change, recovered/resolved | No | Anemia |
| Male, 41 y | LTE (192/225) | Danicopan-danicopan (200 mg) | Ravulizumab (3300 mg) | 1 | 12.1 | 9.2 | 10.7 | 307.0 | 632.0‡ | No | No dose change, recovered/resolved | No | COVID-19 infection |
| Male, 58 y | LTE (393/424) | Danicopan-danicopan (200 mg) | Ravulizumab (3300 mg) | 1 | NA§ | 7.4 | NA§ | 234.0 | 310.0 | No | No dose change, recovered/resolved | No | — |
| Female, 82 y | TP2 (113/127) | Danicopan-danicopan (200 mg) | Ravulizumab (3000 mg) | 2 | 9.5 | 8.7 | 9.3 | 289.0 | 639.0 | No | No dose change, recovered/resolved | No | Skin infection |
| LTE (290/291) | 2 | 10.1 | NA§ | 8.6 | 516.0 | NA§ | No | No dose change, recovered/resolved | No | Food poisoning | |||
| LTE (505/505) | 2 | NA§ | NA§ | NA§ | 286.0 | 387.0 | No | No dose change, recovered/resolved | No | — | |||
| Male, 40 y | LTE (218/219) | Danicopan-danicopan (200 mg) | Ravulizumab (3300 mg) | 1 | 14.8 | NA§ | 13.2 | 255.0 | NA§ | No | No dose change, recovered/resolved | No | Fever |
| Participant . | Reported BTH event . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase (start day/end day)∗ . | Treatment arm (dose) . | C5 inhibitor (dose) . | Severity grade† . | Hb before BTH event, g/dL . | Hb during BTH event, g/dL . | Hb after BTH event, g/dL . | LDH before BTH event, U/L . | LDH at time of BTH event, U/L . | Related to danicopan . | Outcome . | Need for transfusion . | Concurrent AEs . | |
| Male, 54 y | TP2 (127/156) | Danicopan-danicopan (200 mg) | Ravulizumab (3300 mg) | 3 | 11.0 | 7.3 | 13.6 | 447.0 | 336.0 | No | No dose change, recovered/resolved | No | Anemia |
| Male, 41 y | LTE (192/225) | Danicopan-danicopan (200 mg) | Ravulizumab (3300 mg) | 1 | 12.1 | 9.2 | 10.7 | 307.0 | 632.0‡ | No | No dose change, recovered/resolved | No | COVID-19 infection |
| Male, 58 y | LTE (393/424) | Danicopan-danicopan (200 mg) | Ravulizumab (3300 mg) | 1 | NA§ | 7.4 | NA§ | 234.0 | 310.0 | No | No dose change, recovered/resolved | No | — |
| Female, 82 y | TP2 (113/127) | Danicopan-danicopan (200 mg) | Ravulizumab (3000 mg) | 2 | 9.5 | 8.7 | 9.3 | 289.0 | 639.0 | No | No dose change, recovered/resolved | No | Skin infection |
| LTE (290/291) | 2 | 10.1 | NA§ | 8.6 | 516.0 | NA§ | No | No dose change, recovered/resolved | No | Food poisoning | |||
| LTE (505/505) | 2 | NA§ | NA§ | NA§ | 286.0 | 387.0 | No | No dose change, recovered/resolved | No | — | |||
| Male, 40 y | LTE (218/219) | Danicopan-danicopan (200 mg) | Ravulizumab (3300 mg) | 1 | 14.8 | NA§ | 13.2 | 255.0 | NA§ | No | No dose change, recovered/resolved | No | Fever |
TEAEs were determined and assessed by investigators. Data are based on final data cutoff as of 22 March 2024.
NA, not available.
The start day indicates the first report of BTH, and the end day indicates when data of normalization were available. Notably, the end day does not necessarily represent the day data normalized.
Severity grade was based on version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events.
Participant had an LDH value of 2.2 × ULN. The laboratory threshold for LDH ULN was 281 U/L and 330 U/L for male and female participants, respectively.
No value available at the exact time of the event.