Table 4.
Analysis of dropouts and adverse events.
| Author, year | Dropout causes | Adverse events | ||
|---|---|---|---|---|
| A | D | A | D | |
| Wille, 1986 | 1 (4%) Withdrew 1 (4%) UTI 1 (4%) Became dry before started treatment |
1 (4%): Unspecified: | 21 (84%) False alarms 5 (20%) Alarm didn’t work 15 (60%) Alarm didn’t awake the child 15 (60%) Other family members woke instead |
5 (20%) nasal discomfort, 1 (4%) occasional nose bleed, 2 (8%) bad taste in the throat |
| Faraj, 1999 | 36 (49.3%) Did not purchase the alarm | 23 (37.1%) Non-compliant or lost to follow-up | Not mentioned | Not mentioned |
| Ng, 2004 | 5 (14.3%) Ineffective 3 (8.6%) Disturb other family members 2 (5.7%) Discomfort 1 (2.9%) Too cold to get up |
2 (5.3%) Fear of drug dependency | None | None |
| Kwak, 2010 | 1 (2.0%) Poor compliance 3 (6.0%) Withdrew consent |
|||
| 1 (1.9%) Abdominal pain and voiding difficulty 1 (1.9%) Loss of follow-up 1 (1.9%) Withdrew consent |
None | 1 (1.9%) Abdominal pain and voiding difficulty | ||
| Evans, 2011 | 1 (1.7%) Due to TEAEs* 8 (13.6%) Lack of efficacy 13 (22.0%) Patient preference 12 (20.3%) Other reasons |
10 (5.2%) Due to TEAEs* 28 (14.6%) Lack of efficacy 19 (9.9%) Patient preference 21 (10.9%) Other reasons During follow-up 2 (1.0%) due to lack of efficacy 5 (3.0%) other reasons |
During treatment
8 (14.0%) TEAEs*, including 1 (1.7%) Severe: Anxiety, probably related During follow-up 1 (4%) Unrelated |
During treatment
58 (30.2%) TEAEs*, including 3 (1.6%) Headache, related 3 (1.6%) Severe cases: 1 (0.5%) Dysuria and micturition urgency, possibly related to medication 1 (0.5%) Appendicitis, unlikely 1 (0.5%) Rash, unrelated During follow-up 1 (0.9%) mild and related 3 (2.6%) unrelated |
| Ahmed, 2013 | 1 (2.2%) Loss of follow-up 3 (6.7%) Discomfort 4 (8.9%) Ineffective 1 (2.2%) Disturb other family members |
1 (2.2%) Loss of follow-up 3 (6.5%) Fear of drug dependence |
None | None |
| Bolla, 2014 | N/A | N/A | Not mentioned | 4 (13.3%) Temporary asymptomatic hyponatremia |
| Önol, 2015 | 8 (12.3%) Discomfort with device 5 (7.7%) Lack of efficacy 7 (10.8%) Loss follow-up |
4 (5.2%) Loss of follow-up | Not mentioned | Not mentioned |
*Treatment-emergent adverse events (TEAEs) were defined as any unfavorable and unintended sign, symptom or disease temporally (not necessarily causally) associated with use of the product.