Table 5. List of serious adverse events (SAE) occurring in snakebite victims with neurotoxic signs randomized to either a low or a high initial dose of antivenom.

	Nature of the SAE	Seriousness criteria	Relationship to treatment	Outcome
1	Anaphylactic reaction	Life-threatening	Definitely related	Resolved
2	Anaphylactic reaction	Results in death	Probably related	Death
3	Anaphylactic reaction	Life-threatening	Definitely related	Resolved
4	Delayed anaphylactic reaction	Results in death	Probably related	Death
5	Anaphylactic reaction	Life-threatening	Definitely related	Resolved
6	Anaphylactic reaction	Life-threatening	Definitely related	Resolved
7	Gangrene of bitten finger	Prolonged hospitalization and permanent disability	Unlikely to be related	Resolved with sequelae
8	Respiratory failure	Results in death	Not related	Death
9	Cardiac arrest	Life-threatening	Definitely related	Resolved
10	Tracheostomy1	Results in death	Unlikely to be related	Not resolved
11	Sudden death after discharge (unexplained)	Results in death	Unlikely to be related	Not resolved
12	Anaphylactoid reaction	Life-threatening	Probably related	Resolved
13	Overdose2	Overdose	NA	NA
14	Death (unexplained reason)	Results in death	Unlikely to be related	Death
15	Death (overwhelming envenoming)	Results in death	Unlikely to be related	Death
16	Post-anoxic myoclonus	Prolonged hospitalization	Unlikely to be related	Recovered
17	Anaphylactoid reaction	Results in death	Probably related	Death
18	Respiratory failure	Results in death	Unlikely to be related	Death
19	Death (overwhelming envenomation)	Results in death	Unlikely to be related	Death

¹Death consecutive to tracheostomy occurred in the same patient as the cardiac arrest.

²As per trial protocol, overdose of antivenom were to be considered as SAE and reported on expedited basis to the sponsor.