NCT04637594 · ADVERSE EVENTS

Adverse events

Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy · Source last updated 2026-03-20

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: 2.5 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (Immune Checkpoint Inhibitor) CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV	0 / 1	1 / 1	0 / 1
Arm B (Immune Checkpoint Inhibitor) DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV	0 / 2	1 / 2	0 / 2

Group identifiers: EG000: Arm A (Immune Checkpoint Inhibitor) · EG001: Arm B (Immune Checkpoint Inhibitor)

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Rotator cuff injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
4
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Rash maculo-papular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Laryngeal inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Papulopustular rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Hyperkeratosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Myalgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Neoplasms benign, malignant and unspecified - other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Pain in extremity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Flu like symptoms

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
1
description
CONTINUATION OF ICI TREATMENT: Patients receive either pembrolizumab intravenously (IV) over 30 minutes on day 1, nivolumab IV over 30 minutes on days 1 and 15, atezolizumab IV over 30-60 minutes on day 1, durvalumab IV over 60 minutes on days 1 and 15, or avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 21 or 42 days for pembrolizumab, every 21 days for atezolizumab, and 28 days for nivolumab, durvalumab, and avelumab in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Arm A (Immune Checkpoint Inhibitor)
deaths Num Affected
0
deaths Num At Risk
2
description
DISCONTINUATION OF ICI TREATMENT: Patients receiving ICI treatment will discontinue ICI treatment within 1 cycle length after randomization. Cycle length is determined by the ICI regimen the patient is receiving at randomization. At disease progression patients may restart the same ICI treatment they were receiving upon randomization at physician discretion. Pembrolizumab: Given IV Nivolumab: Given IV Atezolizumab: Given IV Durvalumab: Given IV Avelumab: Given IV
id
EG001
other Num Affected
1
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Arm B (Immune Checkpoint Inhibitor)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Rotator cuff injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
4
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Rash maculo-papular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Laryngeal inflammation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Papulopustular rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Hyperkeratosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Myalgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Neoplasms benign, malignant and unspecified - other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
2
num Events
1
term
Pain in extremity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 5.0
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
term
Flu like symptoms

time Frame

2.5 years

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Preserved source evidence · Not medical advice