Table 2.

Summary of adverse events by participant

Participants	AE by MedDRA PT	Related to LPa	Severity	Days in Studyb
Participant 1	Headache	Yes	Mild	3–5
	Vomiting	Yes	Mild	3–5
	Tonsillitis	No	Mild	57–72
	Gingivitis	No	Mild	176–181
Participant 2	Procedural painc	Yes	Mild	2 and 30–32c
	Headachec	Yes	Mild	30–31 and 156–157c
	Falld	No	Severe	287
	Femur fractured	No	Severe	287–289
Participant 3	Increased CSF pressuree	No	Mild	1
	Procedural pain	Yes	Mild	14–18
	Procedural headache	Yes	Moderate	15–18
Participant 4	None reported	–	–	–
Participant 5	Chillsc	Yes	Mild	3 and 15–16c
	Paresthesiac	Yes	Mild	3 and 15–16c
	Vomiting	Yes	Mild	15–16
	Decreased appetite	Yes	Mild	15–18
	Foot deformityc	No	Moderate; Severec	34- and 216f
	Upper respiratory tract infectionc	No	Mild	54–63 and 152–160c
	Urticaria	No	Mild	233–266
Participant 6	None reported	–	–	–

^aAssessed by the Investigator as related to the LP procedure. ^bIndicates start and end date of AE. When same AE occurred twice, 2 ranges are provided. ^cTwo separate events of AE were reported in the same participant. ^dReported as serious AEs. Not related to study treatment and were resolved. ^ePrior to study treatment. ^fThe AE of foot deformity, reported initially on Day 34, did not resolve and was upgraded to severe on Day 216; not resolved prior to the end of study visit. All AEs were classified using MedDRA Version 24.0. AE, adverse event. CSF, cerebrospinal fluid; LP, lumbar puncture. MedDRA PT, Medical Dictionary for Regulatory Activities; Preferred Term.