NCT02210689 · ADVERSE EVENTS

Adverse events

A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women · Source last updated 2020-01-28

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: Baseline to 30 days
Other-event reporting threshold: 0%

Adverse events were collected from participants who were randomized and received the study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Generic Clindamycin Phosphate Vaginal Cream 2% One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	0 / 233	65 / 233	0 / 233
Clindesse (Clindamycin Phosphate Vaginal Cream 2%) One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	0 / 236	79 / 236	0 / 236
Vehicle Cream One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.	0 / 122	45 / 122	0 / 122

Group identifiers: EG000: Generic Clindamycin Phosphate Vaginal Cream 2% · EG001: Clindesse (Clindamycin Phosphate Vaginal Cream 2%) · EG002: Vehicle Cream

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.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
0
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Eye Disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
233
group Id
EG001
num Affected
1
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Eye Irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
0
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Eye pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
2
num At Risk
233
group Id
EG001
num Affected
1
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
11
num At Risk
233
group Id
EG001
num Affected
11
num At Risk
236
group Id
EG002
num Affected
6
num At Risk
122
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
2
num At Risk
236
group Id
EG002
num Affected
4
num At Risk
122
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
233
group Id
EG001
num Affected
3
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
1
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Abdominal tenderness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
0
num At Risk
236
group Id
EG002
num Affected
1
num At Risk
122
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
0
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Dental caries
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
4
num At Risk
233
group Id
EG001
num Affected
2
num At Risk
236
group Id
EG002
num Affected
4
num At Risk
122
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
233
group Id
EG001
num Affected
1
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Flatulence

Complete source fields

description

Adverse events were collected from participants who were randomized and received the study drug.

event Groups

deaths Num Affected
0
deaths Num At Risk
233
description
One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
id
EG000
other Num Affected
65
other Num At Risk
233
serious Num Affected
0
serious Num At Risk
233
title
Generic Clindamycin Phosphate Vaginal Cream 2%
deaths Num Affected
0
deaths Num At Risk
236
description
One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
id
EG001
other Num Affected
79
other Num At Risk
236
serious Num Affected
0
serious Num At Risk
236
title
Clindesse (Clindamycin Phosphate Vaginal Cream 2%)
deaths Num Affected
0
deaths Num At Risk
122
description
One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
id
EG002
other Num Affected
45
other Num At Risk
122
serious Num Affected
0
serious Num At Risk
122
title
Vehicle Cream

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
0
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Eye Disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
233
group Id
EG001
num Affected
1
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Eye Irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
0
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Eye pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
2
num At Risk
233
group Id
EG001
num Affected
1
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
11
num At Risk
233
group Id
EG001
num Affected
11
num At Risk
236
group Id
EG002
num Affected
6
num At Risk
122
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
2
num At Risk
236
group Id
EG002
num Affected
4
num At Risk
122
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
233
group Id
EG001
num Affected
3
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
1
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Abdominal tenderness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
0
num At Risk
236
group Id
EG002
num Affected
1
num At Risk
122
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
233
group Id
EG001
num Affected
0
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Dental caries
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
4
num At Risk
233
group Id
EG001
num Affected
2
num At Risk
236
group Id
EG002
num Affected
4
num At Risk
122
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
233
group Id
EG001
num Affected
1
num At Risk
236
group Id
EG002
num Affected
0
num At Risk
122
term
Flatulence

time Frame

Baseline to 30 days

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Preserved source evidence · Not medical advice