Table 2 |.
AEs by treatment group
| Shared placebo n = 40 | Gantenerumab n = 52 | p a | |
|---|---|---|---|
| Gantenerumab and shared placebo | |||
| AEs (n (%)) | |||
| Injection site reactions | 18 (45) | 47 (90) | <0.0001 |
| Nasopharyngitis | 11 (28) | 20 (38) | 0.3738 |
| Back pain | 11 (28) | 16 (31) | 0.8192 |
| Contact dermatitis | 5 (13) | 10 (19) | 0.5703 |
| Nasal congestion | 4 (10) | 9 (17) | 0.3782 |
| Bronchitis | 5 (13) | 8 (15) | 0.7700 |
| Muscle spasms | <4 (<10) | 8 (15) | - |
| Sinusitis | 4 (10) | 8 (15) | 0.542 |
| Fall | <4 (<10) | 6 (12) | - |
| Oropharyngeal pain | <4 (<10) | 6 (12) | - |
| ARIA post-baseline (n (%)) | |||
| ARIA-E | 1 (3) | 10 (19) | 0.0205 |
| ARIA-Hb associated with ARIA-E (n (%)) | |||
| Microhemorrhage | 1 (3) | 5 (10) | 0.2277 |
| Superficial siderosis | 0 | 2 (4) | 0.5031 |
| ARIA-H not associated with ARIA-E (n (%)) | |||
| Microhemorrhage | 4 (10) | 13 (25) | 0.1028 |
| Superficial siderosis | 0 | 2 (4) | 0.5031 |
| Solanezumab and shared placebo | |||
| AEs (n (%)) | |||
| Headache | 20 (50) | 28 (54) | 0.8337 |
| Nasopharyngitis | 11 (28) | 18 (35) | 0.5049 |
| Post-lumbar puncture syndrome | 11 (28) | 17 (33) | 0.6522 |
| Back pain | 11 (28) | 15 (29) | >0.9999 |
| Sinusitis | 4 (10) | 13 (25) | 0.1028 |
| Influenza | 6 (15) | 12 (23) | 0.4298 |
| Insomnia | 4 (10) | 9 (17) | 0.3782 |
| Rhinorrhea | <4 (<10) | 9 (17) | - |
| Urinary tract infection | 6 (15) | 9 (17) | >0.9999 |
| Depression | 4 (10) | 6 (12) | >0.9999 |
| Pain in extremity | 4 (10) | 6 (12) | >0.9999 |
| Toothache | <4 (<10) | 6 (12) | - |
| ARIA post-baseline (n (%)) | |||
| ARIA-E | 1 (3) | 0 | 0.4348 |
| ARIA-H associated with ARIA-E (n (%)) | |||
| Microhemorrhage | 1 (3) | 0 | 0.4348 |
| Superficial siderosis | 0 | 0 | NA |
| ARIA-H not associated with ARIA-E (n (%)) | |||
| Microhemorrhage | 4 (10) | 6 (12) | >0.9999 |
| Superficial siderosis | 0 | 0 | NA |
Non-ARIA AEs that had an incidence >10% and were more frequent in the active treatment group are presented. AEs that occurred in fewer than 4 participants are listed as <4 to maintain blinding. The same AEs were also collected for mutation-negative participants but are not presented in this table. ARIA-E cases were identified on scheduled safety MRIs. ARIA refers to amyloid-related imaging abnormalities, ARIA-E to amyloid-related imaging abnormalities of cerebral edema and ARIA-H to amyloid-related imaging abnormalities of incident microhemorrhage, superficial siderosis or microhemorrhage. AE and ARIA categories are not mutually exclusive.
Two-sided P values using Fisher’s exact test; P values for AEs that listed placebo as <4 were not provided to maintain blinding.
ARIA due to haemosiderin deposition.