Table 4.
Non-serious adverse events days 1–3 depending on clinical indication for intrathecal gadobutrol
| Days 1–3 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| iNPH (n = 38) | SIH (n = 22) | AC (n = 27) | PC (n = 26) | IIH (n = 22) | cHC (n = 11) | ncHC (n = 3) | Significance | ||
| No non-serious adverse events (N/%) | 14 (37%) | 5 (23%) | 10 (37%) | 0 | 3 (14%) | 3 (27%) | 1 (33%) | P = 0.016 | |
| Headache (N/%) | 6 (16%) | 10 (46%) | 9 (33%) | 22 (85%) | 15 (68%) | 6 (55%) | 1 (33%) | P < 0.001 | |
| Severity | Mild (N/%) | 1 (3%) | 2 (9%) | 0 | 0 | 5 (23%) | 0 | 0 | |
| Moderate (N/%) | 3 (8%) | 5 (23%) | 3 (11%) | 4 (15%) | 0 | 2 (18%) | 0 | P < 0.001 | |
| Severe (N/%) | 2 (5%) | 3 (14%) | 6 (22%) | 18 (69%) | 10 (46%) | 4 (36%) | 1 (33%) | ||
| Nausea (N/%) | 18 (47%) | 11 (50%) | 12 (44%) | 21 (81%) | 14 (64%) | 6 (55%) | 2 (67%) | ns | |
| Severity | Mild (N/%) | 7 (18%) | 6 (27%) | 5 (19%) | 3 (12%) | 1 (5%) | 2 (18%) | 1 (33%) | |
| Moderate (N/%) | 1 (3%) | 2 (9%) | 2 (7%) | 1 (4%) | 4 (18%) | 1 (9%) | 0 | P = 0.044 | |
| Severe (N/%) | 10 (26%) | 3 (14%) | 5 (19%) | 17 (65%) | 9 (41%) | 3 (27%) | 1 (33%) | ||
| Dizziness (N/%) | 6 (16%) | 7 (32%) | 12 (44%) | 20 (77%) | 12 (55%) | 2 (18%) | 1 (33%) | P < 0.001 | |
| Severity | Mild (N/%) | 5 (13%) | 4 (18%) | 5 (19%) | 3 (12%) | 3 (14%) | 0 | 0 | |
| Moderate (N/%) | 1 (3%) | 2 (9%) | 2 (7%) | 7 (27%) | 3 (14%) | 0 | 1 (33%) | P < 0.001 | |
| Severe (N/%) | 0 | 1 (5%) | 5 (19%) | 10 (39%) | 6 (27%) | 2 (18%) | 0 | ||
| Itch/paresthesia (N/%) | 2 (5%) | 4 (18%) | 3 (11%) | 8 (31%) | 1 (5%) | 1 (9%) | 1 (33%) | ns | |
| Urinary incontinence | 0 | 1 (5%) | 0 | 0 | 0 | 0 | 0 | ||
| Fatigue | 0 | 0 | 1 (4%) | 2 (8%) | 1 (5%) | 0 | 0 | ns | |
| Vision problems | 0 | 0 | 0 | 0 | 1 (5%) | 1 (9%) | 0 | ||
| Cognitive impairment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Back pain from spinal puncture | 1 (3%) | 1 (5%) | 3 (11%) | 8 (31%) | 3 (14%) | 2 (18%) | 0 | P = 0.032 | |
| Muscular spasms | 0 | 1 (5%) | 0 | 0 | 0 | 0 | 0 | ||
| Tremor | 0 | 1 (5%) | 0 | 0 | 0 | 0 | 0 | ||
| Chills/warm feeling | 3 (8%) | 1 (5%) | 2 (7%) | 5 (19%) | 3 (14%) | 0 | 0 | ns | |
| Changed tasting experience | 0 | 0 | 0 | 1 (4%) | 1 (5%) | 0 | 1 (33%) | ||
Data presented as number of individuals (percentage in parenthesis). Significance determined by the Pearson chi-square test. Data presented as number of individuals (percentage in parenthesis). iNPH idiopathic normal pressure hydrocephalus, SIH spontaneous intracranial hypotension, AC arachnoid cyst, PC pineal cyst, IIH idiopathic intracranial hypertension, cHC communicating hydrocephalus, ns non-significant