Table 2 All treatment emergent adverse events
From: A randomized, placebo-controlled, cross-over trial of ketamine in Rett syndrome
System Organ Class Preferred Term | Cohort 1 (n = 11) | Cohort 2 (n = 12) | Both Cohorts (n = 23) | |||
|---|---|---|---|---|---|---|
Placebo | Ketamine | Placebo | Ketamine | Placebo | Ketamine | |
# (%) | # (%) | # (%) | # (%) | # (%) | # (%) | |
Number of participants with at least one event | 4 (36.4) | 2 (18.2) | 3 (25.0) | 7 (58.3) | 7 (30.4) | 9 (39.1) |
Gastrointestinal disorders | 2 (18.2) | 1 (9.1) | 1 (8.3) | 3 (25.0) | 3 (13.0) | 4 (17.4) |
 Constipation | 1 (9.1) | 0 | 0 | 0 | 1 (4.3) | 0 |
 Diarrhea | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |
 Eructation | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |
 Vomiting | 1 (9.1) | 1 (9.1) | 1 (8.3) | 1 (8.3) | 2 (8.7) | 2 (8.7) |
General disorders and administration site conditions | 0 | 0 | 1 (8.3) | 1 (8.3) | 1 (4.3) | 1 (4.3) |
 Pyrexia | 0 | 0 | 1 (8.3) | 1 (8.3) | 1 (4.3) | 1 (4.3) |
Infections and infestations | 0 | 0 | 0 | 2 (16.7) | 0 | 2 (8.7) |
 Ear infection | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |
 Nasopharyngitis | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |
Injury, poisoning and procedural complications | 0 | 0 | 1 (8.3) | 1 (8.3) | 1 (4.3) | 1 (4.3) |
 Stoma site irritation | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) | 0 |
 Upper limb fracture | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |
Metabolism and nutrition disorders | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |
 Decreased appetite | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |
Nervous system disorders | 1 (9.1) | 0 | 2 (16.7) | 2 (16.7) | 3 (13) | 2 (8.7) |
 Drooling | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) | 0 |
 Sedation | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |
 Somnolence | 0 | 0 | 1 (8.3) | 1 (8.3) | 1 (4.3) | 1 (4.3) |
 Tonic convulsion | 1 (9.1) | 0 | 0 | 0 | 1 (4.3) | 0 |
Psychiatric disorders | 2 (9.1) | 0 | 1 (8.3) | 1 (8.3) | 3 (13) | 1 (4.3) |
 Insomnia | 1 (9.1) | 0 | 0 | 0 | 1 (4.3) | 0 |
 Irritability | 1 (9.1) | 0 | 0 | 1 (8.3) | 1 (4.3) | 1 (4.3) |
 Restlessness | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) | 0 |
Respiratory, thoracic and mediastinal disorders | 0 | 1 (9.1) | 1 (8.3) | 0 | 1 (4.3) | 1 (4.3) |
 Epistaxis | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) | 0 |
 Rhinorrhea | 0 | 1 (9.1) | 0 | 0 | 0 | 1 (4.3) |
Skin and subcutaneous tissue disorders | 0 | 0 | 0 | 2 (16.7) | 0 | 2 (8.7) |
 Nail discoloration | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |
 Skin irritation | 0 | 0 | 0 | 1 (8.3) | 0 | 1 (4.3) |