| First Author and Year of Publication | McHarm Question 1 | McHarm Question 2 | McHarm Question 3 | McHarm Question 4 | McHarm Question 5 | McHarm Question 6 | McHarm Question 7 | McHarm Question 8 | McHarm Question 9 | McHarm Question 10 | McHarm Question 11 | McHarm Question 11 Explanation | McHarm Question 12 | McHarm Question 13 | McHarm Question 14 | McHarm Question 15 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Szonyi (1995)(Szonyi et al., 1995) | Y | N | Y | Y | Y | Y | N | N | N | N | U | Not Discussed | Y | N | Y | N |
| Malone-Lee (2001)(Malone-Lee et al., 2001) | N | N | N | N | N | Y | N | N | N | N | U | Not Discussed | Y | Y | Y | Y |
| Zinner (2002)(Zinner et al., 2002) | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Van Kerrebroeck (2001)(Van Kerrebroeck et al., 2001) | Y | N | Y | Y | N | Y | N | N | N | N | N | AE in ≥5% in any group | Y | N | Y | N |
| Sand (2004)(Sand et al., 2004) | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Appell (2001)(Appell et al., 2001) | N | N | N | N | Y | U | N | N | Y | N | U | Not Discussed | Y | N | Y | Y |
| Foote (2005)*(Foote et al., 2005) | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Wagg (2006)(Wagg et al., 2006) | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Cardozo (2004)(Cardozo et al., 2004) | N | N | N | Y | Y | N | N | N | Y | N | U | Not Discussed | Y | N | Y | N |
| Chapple (2004)(Chapple et al., 2004b) | N | N | N | Y | Y | N | N | N | Y | N | U | Not Discussed | Y | N | Y | N |
| Chapple (2004)(Chapple et al., 2004a) | N | Y | N | Y | N | Y | N | N | N | N | N | Possible or probable AE in ≥3% in any group | Y | Y | Y | N |
| Chapple (2005)(Chapple et al., 2005) | N | N | Y | N | Y | N | Y | N | Y | N | U | Not Discussed | Y | N | Y | N |
| Minassian (2007)(Minassian et al., 2007) | N | N | N | N | N | Y | N | N | N | N | U | Not Discussed | Y | Y | Y | N |
| Chapple (2007)(Chapple et al., 2007a) | N | N | N | Y | N | Y | N | N | N | N | N | AE in ≥5% in any group | Y | Y | Y | Y |
| Lackner (2008)(Lackner et al., 2008) | N | N | Y | Y | Y | N | Y | N | Y | Y | U | Not Discussed | Y | Y | Y | Y |
| Kraus (2010)(Kraus et al., 2010b) | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Chapple (2007)(Chapple et al., 2007b) | N | N | N | N | Y | U | Y | N | Y | N | N | Treatment-emergent AE in ≥2% in any group | Y | Y | Y | N |
| Nitti (2007)(Nitti et al., 2007) | N | N | N | Y | N | Y | N | N | N | N | N | AE in ≥2% in any group | Y | Y | Y | N |
| Herschorn (2011)(Herschorn et al., 2011) | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Herschorn (2010)(Herschorn et al., 2010a) | Y | N | N | N | Y | N | N | N | Y | Y | U | Not Discussed | Y | Y | Y | Y |
| Sand (2011)(Sand et al., 2011) | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Dmochowski (2008)(Dmochowski et al., 2008) | N | N | N | Y | N | Y | N | N | N | N | N | Not Discussed | N | Y | Y | Y |
| Staskin (2007)(Staskin et al., 2007) | N | N | N | N | N | Y | N | N | Y | N | N | Possible AE in ≥1% in active drug group | Y | Y | Y | N |
| DuBeau (2012)(DuBeau et al., 2012) | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Herschorn (2010)(Herschorn et al., 2010b) | N | N | N | Y | N | Y | N | N | N | N | N | Treatment-emergent AE in ≥2% in active drug group with higher incidence than placebo | Y | Y | Y | N |
| Kaplan (2011)(Kaplan et al., 2011) | N | N | Y | N | Y | N | N | N | N | N | N | Treatment-emergent AE in ≥2% in active drug group with higher incidence than placebo | Y | N | Y | N |
| Wagg (2013)(Wagg et al., 2013) | N | N | N | Y | N | Y | N | N | N | N | N | AE in ≥2% in any group | Y | Y | Y | N |
| Wagg (2014)(Wagg et al., 2014) | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Khullar (2012)(Khullar et al., 2013) | Y | N | Y | Y | N | Y | N | N | N | N | N | AE in ≥2% in any group | Y | Y | Y | N |
| Nitti (2012)(Nitti et al., 2013) | Y | N | N | Y | N | Y | N | N | N | N | N | AE in ≥2% in any group | Y | N | Y | N |
| Herschorn (2013)(Herschorn et al., 2013) | Y | N | N | N | N | Y | N | N | N | Y | N | AE in ≥2% in any group | Y | Y | Y | N |
| DuBeau (2014)(Dubeau et al., 2014) | N | N | N | Y | N | Y | N | N | N | N | N | AE in ≥1% in any group | Y | Y | Y | N |
AE = Adverse Event; N = No; U = Unclear; Y = Yes;
Parent studies were not available for review
Under the “First Author and Year of Publication” columns, included studies are bolded and parent studies not bolded.
McHarm Question 1: Were the harms PRE-DEFINED using standardized or precise definitions?
McHarm Question 2: Were SERIOUS events precisely defined?
McHarm Question 3: Were SEVERE events precisely defined?
McHarm Question 4: Were the number of DEATHS in each study group specified OR were the reason(s) for not specifying them given?
McHarm Question 5: Was the mode of harms collection specified as ACTIVE?
McHarm Question 6: Was the mode of harms collection specified as PASSIVE?
McHarm Question 7: Did the study specify WHO collected the harms?
McHarm Question 8: Did the study specify the TRAINING or BACKGROUND of who ascertained the harms?
McHarm Question 9: Did the study specify the TIMING and FREQUENCY of collection of the harms?
McHarm Question 10: Did the author(s) use STANDARD scale(s) or checklist(s) for harms collection?
McHarm Question 11: Did the authors specify if the harms reported encompass ALL the events collected or a selected SAMPLE?
McHarm Question 12: Was the NUMBER of participants that withdrew or were lost to follow-up specified for each study group?
McHarm Question 13: Was the TOTAL NUMBER of participants affected by harms specified for each study arm?
McHarm Question 14: Did the author(s) specify the NUMBER for each TYPE of harmful event for each study group?
McHarm Question 15: Did the author(s) specify the type of analyses undertaken for harms data?