Page 4 of 11
SUPPLEMENTAL DIGITAL CONTENT 4
Safety Summary
Summary of AEs for the Dolutegravir Single-Entity Study (205893)
AEs by system organ class preferred term, n (%)
Part 1 Part 2
Treatment A DTG 10 mg tablet × 5 tablets swallowed whole
(N=14)
Treatment B DTG 50 mg tablet × 1 tablet
(Ref) swallowed whole
(N=14)
Treatment C DTG 5 mg DT
× 5 tablets dispersed
(N=24)
Treatment D DTG 5 mg DT
× 5 tablets swallowed whole
(N=24)
Treatment E DTG 25 mg tablet × 1 tablet
(Ref) swallowed whole
(N=24)
Any event 1 (7.1) 2 (14.3) 2 (8.3) 2 (8.3) 3 (12.5)
Gastrointestinal disorders 0 2 (14.3) 1 (4.2) 1 (4.2) 0
Diarrhea 0 1 (7.1) 1 (4.2) 0 0
Nausea 0 1 (7.1) 0 0 0
Abdominal pain 0 0 1 (4.2) 0 0
Constipation 0 0 0 1 (4.2) 0
Musculoskeletal and connective tissue
disorders 0 1 (7.1) 0 0 0
Myalgia 0 1 (7.1) 0 0 0
Nervous system disorders 0 1 (7.1) 0 0 0
Headache 0 1 (7.1) 0 0 0
Psychiatric disorders 1 (7.1) 0 0 0 0
Abnormal dreams 1 (7.1) 0 0 0 0
General disorders and administration site
conditions 0 0 1 (4.2) 0 1 (4.2)
Fatigue 0 0 0 0 1 (4.2)
Feeling jittery 0 0 1 (4.2) 0 0
Reproductive system and breast disorders 0 0 0 1 (4.2) 1 (4.2)
Dysmenorrhea 0 0 0 0 1 (4.2)
Vaginal discharge 0 0 0 1 (4.2) 0
Injury, poisoning and procedural
complications 0 0 0 0 1 (4.2)
Skin abrasion 0 0 0 0 1 (4.2)
Skin and subcutaneous tissue disorders 0 0 0 1 (4.2) 0
Acne 0 0 0 1 (4.2) 0
Page 5 of 11
There were no deaths, SAEs, other significant AEs, or AEs leading to withdrawal reported during the study. There were no clinically relevant mean changes from baseline in chemistry, hematology, or urinalysis values during the study and no apparent treatment-related trends were observed. No clinical laboratory evaluations were reported as AEs.
AE, adverse event; Dispersed, dispersed in water and taken immediately; DT, dispersible tablet; DTG, dolutegravir; Ref, reference treatment; SAE, serious AE.
Summary of AEs for the Dolutegravir FDC Study (205894)
AEs by system organ class preferred term, n (%)
Part 1 Part 2
Treatment A ABC/DTG/3TC
600/50/300 mg tablet × 1 (Ref)
whole (N=17)
Treatment B ABC/DTG/3TC
60/5/30 mg DT
× 10 tablets dispersed
(N=17)
Treatment C ABC/DTG/3TC
60/5/30 mg DT
× 10 tablets whole (N=18)
Treatment D DTG 50 mg + 3TC 300 mg
tablets (Ref) whole (N=18)
Treatment E DTG/3TC 5/30 mg DT
× 10 tablets dispersed
(N=18)
Treatment F DTG/3TC 5/30 mg DT
× 10 tablets whole (N=18)
Any event 1 (5.9) 1 (5.9) 2 (11.1) 1 (5.6) 0 1 (5.6)
General disorders and
administration site conditions 0 0 2 (11.1) 0 0 1 (5.6)
Vessel puncture site reaction 0 0 2 (11.1) 0 0 0
Vessel puncture site
erythema 0 0 1 (5.6) 0 0 0
Vessel puncture site pain 0 0 0 0 0 1 (5.6)
Gastrointestinal disorders 1 (5.9) 0 0 0 0 0
Nausea 1 (5.9) 0 0 0 0 0
Infections and infestations 0 1 (5.9) 0 0 0 0
Urinary tract infection 0 1 (5.9) 0 0 0 0
Nervous system disorders 0 0 0 1 (5.6) 0 0
Presyncope 0 0 0 1 (5.6) 0 0
There were no deaths, SAEs, or AEs leading to withdrawal reported during the study. There were no clinically relevant mean changes from baseline in chemistry, hematology, or urinalysis values during the study and no apparent treatment-related trends were observed. No clinical laboratory evaluations were reported as AEs.
AE, adverse event; Dispersed, dispersed in water and taken immediately; DT, dispersible tablet; DTG, dolutegravir; Ref, reference treatment; SAE, serious AE;
Whole, swallowed whole.
