NCT03180307 · ADVERSE EVENTS

Adverse events

OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer · Source last updated 2022-02-04

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: Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
Other-event reporting threshold: 5%

The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Safety Analysis Set The Safety Analysis Set includes all subjects who received any amount of study drug.	22 / 150	34 / 150	2 / 150

Group identifiers: EG000: Safety Analysis Set

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
150
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Clostridium difficile infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Peritonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Postoperative wound infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
3
num At Risk
150
term
Postoperative ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Anastomotic leak
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Post procedural haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Vaginal cuff dehiscence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
150
term
Pleural effusion

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
27
num At Risk
150
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
8
num At Risk
150
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
7
num At Risk
150
term
Abdominal pain

Complete source fields

description

The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.

event Groups

deaths Num Affected
2
deaths Num At Risk
150
description
The Safety Analysis Set includes all subjects who received any amount of study drug.
id
EG000
other Num Affected
34
other Num At Risk
150
serious Num Affected
22
serious Num At Risk
150
title
Safety Analysis Set

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
27
num At Risk
150
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
8
num At Risk
150
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
7
num At Risk
150
term
Abdominal pain

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
150
term
Septic shock
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Clostridium difficile infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Peritonitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Postoperative wound infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
3
num At Risk
150
term
Postoperative ileus
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Anastomotic leak
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Post procedural haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
1
num At Risk
150
term
Vaginal cuff dehiscence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (20.1)
stats
group Id
EG000
num Affected
2
num At Risk
150
term
Pleural effusion

time Frame

Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice