NCT03815344 · ADVERSE EVENTS

Adverse events

Combined Vaginal Misoprostol and Perivascular Vasopressin · Source last updated 2024-01-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 1 hour post surgery
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Standard Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg	0 / 42	0 / 42	0 / 42
Standard-Vaginal Misoprostol Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement . Standard: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg	0 / 32	0 / 32	0 / 32

Group identifiers: EG000: Standard · EG001: Standard-Vaginal Misoprostol

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
42
description
Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
id
EG000
other Num Affected
0
other Num At Risk
42
serious Num Affected
0
serious Num At Risk
42
title
Standard
deaths Num Affected
0
deaths Num At Risk
32
description
Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement . Standard: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle Standard-vaginal misoprostol: 20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
id
EG001
other Num Affected
0
other Num At Risk
32
serious Num Affected
0
serious Num At Risk
32
title
Standard-Vaginal Misoprostol

frequency Threshold

time Frame

1 hour post surgery

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Preserved source evidence · Not medical advice