Overview of treatment-emergent adverse events (TEAEs)
| n (%) | Dose escalation | ATEP | |||||
| Placebo (n=8) | Iberdomide 0.3 mg QOD (n=8) | Iberdomide 0.3 mg QD (n=8) | Iberdomide 0.6/0.3 mg ALTN (n=9) | Iberdomide 0.6 mg QD (n=9) | Iberdomide 0.3 mg QD (n=9) | Iberdomide 0.6/0.3 mg ALTN (n=8) | |
| Any TEAE | 5 (62.5) | 7 (87.5) | 7 (87.5) | 8 (88.9) | 8 (88.9) | 9 (100) | 7 (87.5) |
| Any treatment-related TEAE | 1 (12.5) | 2 (25.0) | 2 (25.0) | 4 (44.4) | 6 (66.7) | 2 (22.2) | 5 (62.5) |
| Severe TEAE | 1 (12.5) | 0 | 0 | 1 (11.1) | 2 (22.2) | 0 | 5 (62.5) |
| Serious TEAE | 2 (25.0) | 0 | 0 | 1 (11.1) | 1 (11.1) | 0 | 4 (50.0) |
| Any serious treatment-related TEAE | 0 | 0 | 0 | 0 | 1 (11.1) | 0 | 0 |
| TEAEs leading to drug withdrawal | 1 (12.5)* | 0 | 0 | 2 (22.2)† | 3 (33.3)‡ | 1 (11.1)§ | 4 (50.0)¶ |
| TEAEs leading to death | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs in >5% of patients** | |||||||
| URTI | 1 (12.5) | 1 (12.5) | 1 (12.5) | 1 (11.1) | 1 (11.1) | 4 (44.4) | 3 (37.5) |
| Diarrhoea | 1 (12.5) | 1 (12.5) | 1 (12.5) | 2 (22.2) | 2 (22.2) | 1 (11.1) | 3 (37.5) |
| Nausea | 1 (12.5) | 1 (12.5) | 3 (37.5) | 3 (33.3) | 0 | 2 (22.2) | 0 |
| Bronchitis | 0 | 0 | 2 (25.0) | 0 | 0 | 3 (33.3) | 3 (37.5) |
| Urinary tract infection | 0 | 1 (12.5) | 0 | 1 (11.1) | 0 | 2 (22.2) | 2 (25.0) |
| Neutropenia | 0 | 0 | 0 | 1 (11.1) | 2 (22.2) | 1 (11.1) | 1 (12.5) |
| Pneumonia | 0 | 0 | 0 | 2 (22.2) | 1 (11.1) | 1 (11.1) | 1 (12.5) |
| Cough | 0 | 0 | 0 | 1 (11.1) | 1 (11.1) | 0 | 2 (25.0) |
| Nasopharyngitis | 1 (12.5) | 0 | 0 | 0 | 1 (11.1) | 2 (22.2) | 0 |
| Pain in extremity | 0 | 1 (12.5) | 0 | 0 | 1 (11.1) | 2 (22.2) | 0 |
| Vitamin D deficiency†† | 0 | 0 | 1 (12.5) | 2 (22.2) | 1 (11.1) | 0 | 0 |
| Vomiting | 1 (12.5) | 0 | 1 (12.5) | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Maculopapular rash | 0 | 1 (12.5) | 0 | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Musculoskeletal pain | 0 | 0 | 0 | 0 | 0 | 1 (11.1) | 2 (25.0) |
| Osteoarthritis | 0 | 0 | 0 | 1 (11.1) | 0 | 2 (22.2) | 0 |
| Sinusitis | 0 | 0 | 0 | 0 | 0 | 2 (22.2) | 1 (12.5) |
*Deep vein thrombosis.
†Pneumonia/diarrhoea and ecchymosis/maculopapular rash.
‡Pneumonia, dermatitis and neutropenia.
§Small fibre neuropathy.
¶Bronchitis, gastroenteritis, decreased neutrophil count, oral candidiasis, and pulmonary embolism.
**In combined dose-escalation and ATEP safety populations (N=59).
††Present prior to treatment.
ALTN, alternating once daily; ATEP, active treatment extension phase; QD, once daily; QOD, every other day; URTI, upper respiratory tract infection.