NCT03146650 · ADVERSE EVENTS

Adverse events

Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer · Source last updated 2024-01-18

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: Adverse Events (AEs) were collected over a 3 year period, and is still continuing (2 patients still on treatment). For other AEs, each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. For Serious AEs, each patient was followed at time of consent and 100 days post last treatment. 1 Cycle = 84 days/12 weeks and the range of cycles attempted was 1-11.
Other-event reporting threshold: 0%

A patient who was registered and signed consent but did not initiate treatment is included as at risk for SAE but not at risk for other AEs. This patient never received treatment on study. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivolumab + Ipilimumab Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).	16 / 25	24 / 24	11 / 24

Group identifiers: EG000: Nivolumab + Ipilimumab

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
notes
The patient also experienced tumor pain at the time of this event.
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Spinal fracture
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced increased blood bilirubin and cholecystitis at the time of this event.
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced an increase in Aspartate aminotransferase at the time of this event.
organ System
Investigations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Neck pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced constipation at the time of this event.
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One patient also experienced nausea and diarrhea at the time of this event.
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced acute kidney injury and alkalosis at the time of this event.
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced muscle weakness in the right lower limb at the time of this event.
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Pain Right Lower Limb

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
3
num At Risk
24
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
6
num At Risk
24
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
10
num At Risk
24
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
24
term
Amnesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
15
num At Risk
24
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Anisocoria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
7
num At Risk
24
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
3
num At Risk
24
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Arthralgia

Complete source fields

description

event Groups

deaths Num Affected
11
deaths Num At Risk
24
description
Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
id
EG000
other Num Affected
24
other Num At Risk
24
serious Num Affected
16
serious Num At Risk
25
title
Nivolumab + Ipilimumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
3
num At Risk
24
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
6
num At Risk
24
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
10
num At Risk
24
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
24
term
Amnesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
15
num At Risk
24
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Anisocoria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
7
num At Risk
24
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
3
num At Risk
24
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
24
term
Arthralgia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced tumor pain at the time of this event.
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Spinal fracture
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced increased blood bilirubin and cholecystitis at the time of this event.
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced an increase in Aspartate aminotransferase at the time of this event.
organ System
Investigations
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Neck pain
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced constipation at the time of this event.
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
nausea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One patient also experienced nausea and diarrhea at the time of this event.
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced acute kidney injury and alkalosis at the time of this event.
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
The patient also experienced muscle weakness in the right lower limb at the time of this event.
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.03)
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Pain Right Lower Limb

time Frame

Adverse Events (AEs) were collected over a 3 year period, and is still continuing (2 patients still on treatment). For other AEs, each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. For Serious AEs, each patient was followed at time of consent and 100 days post last treatment. 1 Cycle = 84 days/12 weeks and the range of cycles attempted was 1-11.

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Preserved source evidence · Not medical advice