Summary of AEs and SAEs with ITB therapy or CMM (modified ITT population)
| ITB-I (n=25) | CMM+non-implanted (n=35) | |
| All AEs | 24 (96.0) (155) | 22 (62.9) (79) |
| All serious AEs | 13 (52.0) (35) | 10 (28.6) (24) |
| Resulted in patient death | 1 (4.0) (1)* | 0 (0.0) (0) |
| All treatment-emergent AEs† | 24 (96.0) (149) | 22 (62.9) (77) |
| Drug-related (ADRs) | 14 (56.0) (39)‡ | 6 (17.1) (12) |
| Device-related (ADEs) | 9 (36.0) (16) | NA |
| Procedure-related | 6 (24.0) (9) | 1 (2.9) (1)§ |
| Serious treatment-emergent AEs | 12 (48.0) (34) | 10 (28.6) (24) |
| Drug-related (SADRs) | 6 (24.0) (7) | 1 (2.9) (1) |
| Device-related (SADEs) | 4 (16.0) (4)¶ | NA |
| Procedure-related | 1 (4.0) (1)** | 0 (0.0) (0) |
| Treatment-emergent AEs by intensity | ||
| Mild | 22 (88.0) (89) | 19 (54.3) (43) |
| Moderate | 16 (64.0) (33) | 13 (37.1) (20) |
| Severe | 7 (28.0) (10) | 4 (11.4) (4) |
Data presented are number of patients (% of patients) and (number of AE reports).
*Event of accidental alcohol poisoning.
†AEs were treatment-emergent if not present prior to study treatment initiation or if any event already present worsened in either intensity or frequency following exposure to study treatment. Start of treatment refers to the start of the ITB test for patients in the ITB arm and randomisation for patients in the CMM arm.
‡Includes two unexpected events of faecal impaction reported for two patients with ITB-I (one event was classified as a SUSAR).
§One patient randomised to the ITB arm experienced a procedure-related event during the ITB test but was not implanted.
¶The four SADEs included device dislocation, device occlusion, implant site infection, and intracranial hypotension.
**One event of pain was considered related to the implant procedure.
ADE, adverse device effect; ADR, adverse drug reaction; AE, adverse event; CMM, conventional medical management; ITB-I, intrathecal baclofen-implanted; ITT, intention-to-treat; SADE, serious adverse device effect; SADR, serious adverse drug reaction; SAE, serious adverse event; SUSAR, suspected unexpected serious adverse reaction.