Study: NCT02354144

Adverse event: Unusual pain during anal sex
Serious: no
Organ System: Product Issues
Notes: AE reported in calendar. Non-response for 27 in the carrageenan and 31 in the placebo arm.
Frequency: 4 affected / 75 at risk

Adverse event: Rectal bleeding in between anal sex
Serious: no
Organ System: Product Issues
Notes: AE reported in calendar. Non-response for 27 in the carrageenan and 31 in the placebo arm.
Frequency: 6 affected / 75 at risk

Adverse event: Unusual abdominal pain
Serious: no
Organ System: Product Issues
Notes: AE reported in calendar. Non-response for 27 in the carrageenan and 31 in the placebo arm.
Frequency: 2 affected / 75 at risk

Adverse event: Anal discharge
Serious: no
Organ System: Product Issues
Notes: AE reported in calendar. Non-response for 27 in the carrageenan and 31 in the placebo arm.
Frequency: 2 affected / 75 at risk

Adverse event: Itching, burning, edema or pain in the anorectal area
Serious: no
Organ System: Product Issues
Notes: AE reported in calendar. Non-response for 27 in the carrageenan and 31 in the placebo arm.
Frequency: 4 affected / 75 at risk

Adverse event: Other
Serious: no
Organ System: Product Issues
Notes: AE reported in calendar. Non-response for 27 in the carrageenan and 31 in the placebo arm.
Frequency: 3 affected / 75 at risk

Adverse event: Use of the gel caused discomfort/adverse reactions to you
Serious: no
Organ System: Product Issues
Notes: AE reported in survey. Non-response for 3 participants in the carrageenan and 5 in the placebo arm.
Frequency: 18 affected / 99 at risk

Adverse event: Use of the gel caused discomfort/adverse reactions to your partner(s)
Serious: no
Organ System: Product Issues
Notes: AE reported in survey. Non-response for 3 participants in the carrageenan and 5 in the placebo arm.
Frequency: 13 affected / 99 at risk

Adverse event: Reported bleeding following receptive anal intercourse
Serious: no
Organ System: Product Issues
Notes: AE reported in survey. Non-response for 7 participants in the carrageenan and 7 in the placebo arm.
Frequency: 47 affected / 95 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 6 affected / 102 at risk

Adverse event: Erythema
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 6 affected / 102 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 4 affected / 102 at risk

Adverse event: Inflammation
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 2 affected / 102 at risk

Adverse event: Fissures
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 3 affected / 102 at risk

Adverse event: Abscesses
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 1 affected / 102 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 11 affected / 102 at risk

Adverse event: Venereal warts or condylomas
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey. Non-response for 7 participants in the carrageenan and 16 in the placebo arm.
Frequency: 2 affected / 95 at risk

Adverse event: Chlamydia
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 14 affected / 102 at risk

Adverse event: Anal or genital herpes
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 5 affected / 102 at risk

Adverse event: Syphilis
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 7 affected / 102 at risk

Adverse event: Gonorrhoea
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 23 affected / 102 at risk

Adverse event: HIV
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 1 affected / 102 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: Death, related to underlying HIV infection complicated by drug use.
Frequency: 1 affected / 108 at risk

Adverse event: Flatulence, constipation, urgency and/or fecal incontinence or diarrhea
Serious: no
Organ System: Product Issues
Notes: AE reported in calendar. Non-response for 27 in the carrageenan and 31 in the placebo arm.
Frequency: 1 affected / 77 at risk

Adverse event: Other
Serious: no
Organ System: Product Issues
Notes: AE reported in calendar. Non-response for 27 in the carrageenan and 31 in the placebo arm.
Frequency: 1 affected / 77 at risk

Adverse event: Use of the gel caused discomfort/adverse reactions to you
Serious: no
Organ System: Product Issues
Notes: AE reported in survey. Non-response for 3 participants in the carrageenan and 5 in the placebo arm.
Frequency: 8 affected / 103 at risk

Adverse event: Use of the gel caused discomfort/adverse reactions to your partner(s)
Serious: no
Organ System: Product Issues
Notes: AE reported in survey. Non-response for 3 participants in the carrageenan and 5 in the placebo arm.
Frequency: 2 affected / 105 at risk

Adverse event: Reported bleeding following receptive anal intercourse
Serious: no
Organ System: Product Issues
Notes: AE reported in survey. Non-response for 7 participants in the carrageenan and 7 in the placebo arm.
Frequency: 43 affected / 101 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 7 affected / 108 at risk

Adverse event: Erythema
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 9 affected / 108 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 2 affected / 108 at risk

Adverse event: Fissures
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 2 affected / 108 at risk

Adverse event: Abscesses
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 1 affected / 108 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Product Issues
Notes: Conditions reported by nurse at the clinic visit.
Frequency: 7 affected / 108 at risk

Adverse event: Venereal warts or condylomas
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey. Non-response for 7 participants in the carrageenan and 16 in the placebo arm.
Frequency: 3 affected / 92 at risk

Adverse event: Chlamydia
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 12 affected / 108 at risk

Adverse event: Lymphogranuloma vereneum
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 1 affected / 108 at risk

Adverse event: Anal or genital herpes
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 5 affected / 108 at risk

Adverse event: Syphilis
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 7 affected / 108 at risk

Adverse event: Gonorrhoea
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 10 affected / 108 at risk

Adverse event: Ulcers or genital sores
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 1 affected / 108 at risk

Adverse event: Hepatitis B
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 1 affected / 108 at risk

Adverse event: Hepatitis C
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 2 affected / 108 at risk

Adverse event: Anal precancer
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 1 affected / 108 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Product Issues
Notes: Infections/conditions reported by participant in survey.
Frequency: 1 affected / 108 at risk