NCT01903993 · ADVERSE EVENTS

Adverse events

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR" · Source last updated 2019-10-02

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: From the first study drug to the data cutoff date: 31 August 2018
Other-event reporting threshold: 5%

Treatment-emergent adverse events are reported here and they include all adverse events that occurred on or after first dose of study drug until 30 days after last administration of study drug or initiation of another non-protocol anti-cancer therapy after the last administration of study drug, or clinical data cutoff date, whichever occurs first. Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Docetaxel Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.	46 / 135	125 / 135	118 / 143
Atezolizumab Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.	53 / 142	127 / 142	121 / 144

Group identifiers: EG000: Docetaxel · EG001: Atezolizumab

Serious 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
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Peripheral embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
2
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Peripheral ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Superior vena cava syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Venous stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Tumour associated fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
135
num Events
2
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Oedema peripheral

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
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
135
num Events
4
group Id
EG001
num Affected
9
num At Risk
142
num Events
9
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
22
num At Risk
135
num Events
28
group Id
EG001
num Affected
16
num At Risk
142
num Events
26
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
6
num At Risk
135
num Events
8
group Id
EG001
num Affected
12
num At Risk
142
num Events
13
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
55
num At Risk
135
num Events
87
group Id
EG001
num Affected
55
num At Risk
142
num Events
82
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
13
num At Risk
135
num Events
18
group Id
EG001
num Affected
9
num At Risk
142
num Events
11
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
10
num At Risk
135
num Events
11
group Id
EG001
num Affected
6
num At Risk
142
num Events
7
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
16
num At Risk
135
num Events
19
group Id
EG001
num Affected
23
num At Risk
142
num Events
28
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
11
num At Risk
135
num Events
12
group Id
EG001
num Affected
24
num At Risk
142
num Events
26
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
11
num At Risk
135
num Events
11
group Id
EG001
num Affected
20
num At Risk
142
num Events
24
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
27
num At Risk
135
num Events
38
group Id
EG001
num Affected
28
num At Risk
142
num Events
53
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
15
num At Risk
135
num Events
23
group Id
EG001
num Affected
3
num At Risk
142
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
33
num At Risk
135
num Events
40
group Id
EG001
num Affected
45
num At Risk
142
num Events
61
term
Cough

Complete source fields

description

event Groups

deaths Num Affected
118
deaths Num At Risk
143
description
Participants received docetaxel 75 milligram per squared meters (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
id
EG000
other Num Affected
125
other Num At Risk
135
serious Num Affected
46
serious Num At Risk
135
title
Docetaxel
deaths Num Affected
121
deaths Num At Risk
144
description
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
id
EG001
other Num Affected
127
other Num At Risk
142
serious Num Affected
53
serious Num At Risk
142
title
Atezolizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
4
num At Risk
135
num Events
4
group Id
EG001
num Affected
9
num At Risk
142
num Events
9
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
22
num At Risk
135
num Events
28
group Id
EG001
num Affected
16
num At Risk
142
num Events
26
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
6
num At Risk
135
num Events
8
group Id
EG001
num Affected
12
num At Risk
142
num Events
13
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
55
num At Risk
135
num Events
87
group Id
EG001
num Affected
55
num At Risk
142
num Events
82
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
13
num At Risk
135
num Events
18
group Id
EG001
num Affected
9
num At Risk
142
num Events
11
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
10
num At Risk
135
num Events
11
group Id
EG001
num Affected
6
num At Risk
142
num Events
7
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
16
num At Risk
135
num Events
19
group Id
EG001
num Affected
23
num At Risk
142
num Events
28
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
11
num At Risk
135
num Events
12
group Id
EG001
num Affected
24
num At Risk
142
num Events
26
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
11
num At Risk
135
num Events
11
group Id
EG001
num Affected
20
num At Risk
142
num Events
24
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
27
num At Risk
135
num Events
38
group Id
EG001
num Affected
28
num At Risk
142
num Events
53
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
15
num At Risk
135
num Events
23
group Id
EG001
num Affected
3
num At Risk
142
num Events
4
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
33
num At Risk
135
num Events
40
group Id
EG001
num Affected
45
num At Risk
142
num Events
61
term
Cough

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Peripheral embolism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
2
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Peripheral ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Superior vena cava syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Venous stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Cancer pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Tumour associated fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
2
num At Risk
135
num Events
2
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
1
num At Risk
135
num Events
1
group Id
EG001
num Affected
0
num At Risk
142
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.1)
stats
group Id
EG000
num Affected
0
num At Risk
135
num Events
0
group Id
EG001
num Affected
1
num At Risk
142
num Events
1
term
Oedema peripheral

time Frame

From the first study drug to the data cutoff date: 31 August 2018

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

Preserved source evidence · Not medical advice