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. 2021 Aug 5;2021(8):CD009149. doi: 10.1002/14651858.CD009149.pub3
Study Adverse events
 
Adewuya 2019  
 
 
At 12 months, compared with the stepped care intervention group, the enhanced usual care group reported significantly more deaths (15/451; 3.3% vs 3/456; 0.6%) and more cases of deliberate
self‐harm (35/451; 7.8% vs 10/456; 2.2%)
Gureje 2019 (STEPCARE)
  At 12 months, 17 deaths had occurred in the intervention group (total 562) and 16 in the control group (total 473). Deaths were due to hypertension or heart disease in 8 patients, tuberculosis in 6 patients, diabetes in 2 patients, liver failure in 3 patients, typhoid fever in 2 patients, asthma in 2 patients, cancer in 1 patient, and old age or unknown causes in 9 patients. One patient developed psychosis and 1 developed bipolar disorder in the intervention group, and 1 developed bipolar disorder in the control group. Suicidal ideation was reported in 57 participants in the intervention group (10%) and in 66 participants in the control group (14%). All adverse events were deemed not related to study procedures
 
Jenkins 2013 No deaths in either arm 
No reported mention of suicide attempt 
Indu 2018
  No serious adverse events including new onset of suicidality or bipolar disorder or psychotic features  
Patel 2010
  There were 7 serious adverse events (3 deaths and 4 suicide attempts) in the collaborative stepped care group and 12 in the enhanced usual care group (6 deaths and 6 suicide attempts). None of the deaths were the result of suicide