All attributable AEs and all SAEs observed in the phase 1 dose-finding study (including continuation phase) and the expansion cohorts
| AEs . | Grade 1 events . | Grade 2 events . | Grade 3 events . | Grade 4 events . | Total no. of events . | Total no. of patients . | AE attribution . |
|---|---|---|---|---|---|---|---|
| Phase 1 study | |||||||
| Related AEs | |||||||
| Weight gain | 3 | 3 | 1 | 0 | 7 | 6 | Possibly related |
| Investigations, prolonged PFA 100∗ | 1 | 0 | 0 | 0 | 1 | 1 | Possibly related |
| Unrelated SAEs | |||||||
| Anaphylaxis (to platelets) | 0 | 0 | 1 | 0 | 1 | 1 | NA |
| Infection, norovirus/gastroenteritis | 0 | 0 | 1 | 0 | 1 | 1 | NA |
| Lung infection, pneumonia | 0 | 0 | 1 | 0 | 1 | 1 | NA |
| Expansion cohort | |||||||
| Related AEs | |||||||
| Constipation | 1 | 0 | 0 | 0 | 1 | 1 | Possibly related |
| Diarrhea | 0 | 2 | 0 | 0 | 2 | 2 | Possibly related |
| Gastroesophageal reflux disease | 2 | 0 | 0 | 0 | 2 | 2 | Possibly related |
| Weight gain | 2 | 1 | 0 | 0 | 3 | 3 | Possibly related (n = 2), Probably related (n = 1) |
| Unrelated SAEs | |||||||
| Urinary tract infection | 0 | 0 | 2 | 0 | 2 | 1 | NA |
| Infection, gastroenteritis | 0 | 0 | 2 | 0 | 2 | 2 | NA |
| AEs . | Grade 1 events . | Grade 2 events . | Grade 3 events . | Grade 4 events . | Total no. of events . | Total no. of patients . | AE attribution . |
|---|---|---|---|---|---|---|---|
| Phase 1 study | |||||||
| Related AEs | |||||||
| Weight gain | 3 | 3 | 1 | 0 | 7 | 6 | Possibly related |
| Investigations, prolonged PFA 100∗ | 1 | 0 | 0 | 0 | 1 | 1 | Possibly related |
| Unrelated SAEs | |||||||
| Anaphylaxis (to platelets) | 0 | 0 | 1 | 0 | 1 | 1 | NA |
| Infection, norovirus/gastroenteritis | 0 | 0 | 1 | 0 | 1 | 1 | NA |
| Lung infection, pneumonia | 0 | 0 | 1 | 0 | 1 | 1 | NA |
| Expansion cohort | |||||||
| Related AEs | |||||||
| Constipation | 1 | 0 | 0 | 0 | 1 | 1 | Possibly related |
| Diarrhea | 0 | 2 | 0 | 0 | 2 | 2 | Possibly related |
| Gastroesophageal reflux disease | 2 | 0 | 0 | 0 | 2 | 2 | Possibly related |
| Weight gain | 2 | 1 | 0 | 0 | 3 | 3 | Possibly related (n = 2), Probably related (n = 1) |
| Unrelated SAEs | |||||||
| Urinary tract infection | 0 | 0 | 2 | 0 | 2 | 1 | NA |
| Infection, gastroenteritis | 0 | 0 | 2 | 0 | 2 | 2 | NA |
Weight gain grades per common terminology criteria for adverse effects, unexpected or abnormal increase in overall body weight; greater than baseline growth curve. Grade 1 (5% to <10% from baseline), grade 2 (10% to <20% from baseline), and grade 3 (>20% from baseline).
NA, Not applicable; PFA, platelet function analysis.
Platelet function assay-100.