Table 2.
Trials MEM-MD-57A Part 2 and MEM-MD-67: Common TEAEs (Safety Population), n (%)
| MEM-MD-57A Part 2 (12 Weeks) | MEM-MD-67 (48 Weeks) | ||
|---|---|---|---|
| TEAE | Placebo (n = 61) | Mem (n = 60) | Mem (n = 102) |
| Any TEAE | 47 (77.0) | 51 (85.0) | 85 (83.3) |
| TEAEs with incidence ≥3% in either group in trial MEM-MD-57A, Part 2 | |||
| Upper respiratory tract infection | 7 (11.5) | 6 (10.0) | 15 (14.7) |
| Cough | 3 (4.9) | 6 (10.0) | 10 (9.8) |
| Irritability | 3 (4.9) | 5 (8.3) | 7 (6.9) |
| Aggression | 3 (4.9) | 5 (8.3) | 8 (7.8) |
| Vomiting | 6 (9.8) | 4 (6.7) | 8 (7.8) |
| Insomnia | 3 (4.9) | 4 (6.7) | 8 (7.8) |
| Influenza | 2 (3.3) | 4 (6.7) | 5 (4.9) |
| Agitation | 1 (1.6) | 4 (6.7) | 6 (5.9) |
| Headache | 3 (4.9) | 3 (5.0) | 7 (6.9) |
| Rhinorrhea | 0 | 3 (5.0) | 3 (2.9) |
| Nasopharyngitis | 6 (9.8) | 2 (3.3) | 7 (6.9) |
| Pyrexia | 4 (6.6) | 2 (3.3) | 6 (5.9) |
| Diarrhea | 3 (4.9) | 2 (3.3) | 5 (4.9) |
| Ear infection | 1 (1.6) | 2 (3.3) | 5 (4.9) |
| Laceration | 1 (1.6) | 2 (3.3) | 0 |
| Rhinitis, allergic | 1 (1.6) | 2 (3.3) | 5 (4.9) |
| Stereotypy | 1 (1.6) | 2 (3.3) | 5 (4.9) |
| Affective disorder | 0 | 2 (3.3) | 1 (1.0) |
| Enuresis | 0 | 2 (3.3) | 2 (2.0) |
| Frequent bowel movements | 0 | 2 (3.3) | 1 (1.0) |
| Nasal congestion | 5 (8.2) | 1 (1.7) | 8 (7.8) |
| Psychomotor hyperactivity | 4 (6.6) | 1 (1.7) | 6 (5.9) |
| Abdominal pain, upper | 3 (4.9) | 1 (1.7) | 4 (3.9) |
| Oropharyngeal pain | 3 (4.9) | 1 (1.7) | 2 (2.0) |
| Abnormal behavior | 2 (3.3) | 1 (1.7) | 1 (1.0) |
| Nausea | 2 (3.3) | 1 (1.7) | 2 (2.0) |
| Anxiety | 4 (6.6) | 0 | 4 (3.9) |
| Seasonal allergy | 3 (4.9) | 0 | 9 (8.8) |
| Abdominal pain | 2 (3.3) | 0 | 1 (1.0) |
| Nosebleed (epistaxis) | 2 (3.3) | 0 | 3 (2.9) |
| Additional TEAEs, with occurrence ≥3% in trial MEM-MD-67 | |||
| Weight increaseda | 0 | 0 | 9 (8.8) |
| Constipation | 1 (1.6) | 1 (1.7) | 7 (6.9) |
| Initial insomnia | 1 (1.6) | 1 (1.7) | 4 (3.9) |
| Pharyngitis, streptococcal | 0 | 1 (1.7) | 4 (3.9) |
a
Post-hoc analyses of age-adjusted changes in body weight indicates that most instances of weight gain in the trial MEM-MD-67 were associated with children's growth (data not shown).
TEAE categories are ordered by decreasing incidence in the memantine group.
Mem, extended-release memantine; TEAE, treatment-emergent adverse event.