NCT03081689 · ADVERSE EVENTS

Adverse events

Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients · Source last updated 2024-12-04

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: 40 months
Other-event reporting threshold: 5%

The severity of AE will be determined using CTCAE version 4.0

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm 1 Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W	3 / 46	43 / 46	1 / 46

Group identifiers: EG000: Arm 1

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
Blood and lymphatic system disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
1
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
2
num At Risk
46
num Events
2
term
Increased lipase

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
General disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
23
num At Risk
46
num Events
51
term
Asthenia or fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
17
num At Risk
46
num Events
17
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
15
num At Risk
46
num Events
20
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
13
num At Risk
46
num Events
15
term
Neurotoxicity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
12
num At Risk
46
num Events
19
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
11
num At Risk
46
num Events
18
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
19
num At Risk
46
num Events
40
term
Skin disorders (rash)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
9
num At Risk
46
num Events
14
term
Myalgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
8
num At Risk
46
num Events
12
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
9
num At Risk
46
num Events
16
term
Decreased appetite or anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
8
num At Risk
46
num Events
12
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
8
num At Risk
46
num Events
12
term
Paraesthesia

Complete source fields

description

The severity of AE will be determined using CTCAE version 4.0

event Groups

deaths Num Affected
1
deaths Num At Risk
46
description
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months Nivolumab 360 mg: Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months Paclitaxel 200mg/m2: Paclitaxel 200mg/m2 IV Q3W Carboplatin AUC 6: Carboplatin AUC 6 IV Q3W
id
EG000
other Num Affected
43
other Num At Risk
46
serious Num Affected
3
serious Num At Risk
46
title
Arm 1

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
23
num At Risk
46
num Events
51
term
Asthenia or fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
17
num At Risk
46
num Events
17
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
15
num At Risk
46
num Events
20
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
13
num At Risk
46
num Events
15
term
Neurotoxicity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
12
num At Risk
46
num Events
19
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
11
num At Risk
46
num Events
18
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
19
num At Risk
46
num Events
40
term
Skin disorders (rash)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
9
num At Risk
46
num Events
14
term
Myalgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
8
num At Risk
46
num Events
12
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
9
num At Risk
46
num Events
16
term
Decreased appetite or anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
8
num At Risk
46
num Events
12
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
8
num At Risk
46
num Events
12
term
Paraesthesia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
1
num At Risk
46
num Events
1
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
12.1
stats
group Id
EG000
num Affected
2
num At Risk
46
num Events
2
term
Increased lipase

time Frame

40 months

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

Preserved source evidence · Not medical advice