From: Monitoring antimalarial safety and tolerability in clinical trials: A case study from Uganda
Trial | Kampala 1 | UMSP 1 | UMSP 2 | UMSP 3 | UMSP 4 | Kampala 2 |
---|---|---|---|---|---|---|
Study site(s) | Kampala | Kyenjojo, Mubende, Kanungu | Jinja, Arua, Tororo, Apac | Tororo | Apac | Kampala |
Years conducted | August 2002 – July 2003 | December 2002 – June 2003 | November 2002 – May 2004 | December 2004 – July 2005 | May – July 2006 | November 2004 – May 2007 |
Regimens evaluated* | CQ+SP | CQ+SP | CQ+SP | AS+AQ | AL | AQ+SP |
 | AQ+SP | AQ+SP | AQ+SP | AL | DP | AS+AQ |
 | AS+AQ |  | AS+AQ |  |  | AL |
Duration of follow-up | 28 days | 28 days | 28 days | 42 days | 42 days | 42 days |
Age range of participants | 0.5 – 10 years | ≥ 6 months | ≥ 6 months | 1 – 10 years | 0.5 – 10 years | 1 – 10 years |
Total study treatments | 400 | 1105 | 2160 | 408 | 421 | 1120 †|
Efficacy outcome assigned | 384 (96%) | 1057 (96%) | 2081 (96%) | 403 (99%) | 417 (99%) | 1108 (99%) |
Total SAEs | 16 | 41 | 20 | 2 | 6 | 18 |
   Convulsions | 4 | 15 | 4 | 1 | 3 | 9 |
   Altered mental status | 1 | 0 | 2 | 0 | 0 | 0 |
   Anemia | 5 | 6 | 3 | 0 | 0 | 0 |
   Vomiting | 2 | 13 | 1 | 0 | 0 | 1 |
   Weakness | 0 | 3 | 1 | 0 | 0 | 2 |
   Respiratory illness | 1 | 1 | 4 | 1 | 0 | 2 |
   Other | 3 | 3 | 5 | 0 | 3 | 4 |