NCT03427411 · ADVERSE EVENTS

Adverse events

M7824 in Subjects With HPV Associated Malignancies · Source last updated 2023-03-28

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: Date treatment consent signed to date off study, approximately 42 months and 28 days for the naïve group, and 40 months and 16 days for the refractory group.
Other-event reporting threshold: 0%

One participant enrolled in the refractory group was a screen failure and was not treated.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.	19 / 30	30 / 30	18 / 30
Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.	21 / 26	26 / 26	22 / 26

Group identifiers: EG000: Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks · EG001: Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks

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
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
4
group Id
EG001
num Affected
3
num At Risk
26
num Events
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
6
group Id
EG001
num Affected
6
num At Risk
26
num Events
12
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Bile duct stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Blood bilirubin increased

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 (5.0)
stats
group Id
EG000
num Affected
8
num At Risk
30
num Events
11
group Id
EG001
num Affected
7
num At Risk
26
num Events
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
30
num Events
2
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
2
num At Risk
26
num Events
2
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
30
num Events
5
group Id
EG001
num Affected
4
num At Risk
26
num Events
4
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
4
num At Risk
26
num Events
4
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
30
num Events
3
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Anal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
19
num At Risk
30
num Events
44
group Id
EG001
num Affected
19
num At Risk
26
num Events
53
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
10
num At Risk
30
num Events
10
group Id
EG001
num Affected
12
num At Risk
26
num Events
16
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Anosmia

Complete source fields

description

One participant enrolled in the refractory group was a screen failure and was not treated.

event Groups

deaths Num Affected
18
deaths Num At Risk
30
description
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
id
EG000
other Num Affected
30
other Num At Risk
30
serious Num Affected
19
serious Num At Risk
30
title
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
deaths Num Affected
22
deaths Num At Risk
26
description
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
id
EG001
other Num Affected
26
other Num At Risk
26
serious Num Affected
21
serious Num At Risk
26
title
Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
8
num At Risk
30
num Events
11
group Id
EG001
num Affected
7
num At Risk
26
num Events
10
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
30
num Events
2
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
2
num At Risk
26
num Events
2
term
Agitation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
30
num Events
5
group Id
EG001
num Affected
4
num At Risk
26
num Events
4
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
4
num At Risk
26
num Events
4
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Allergic rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
30
num Events
3
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Anal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
19
num At Risk
30
num Events
44
group Id
EG001
num Affected
19
num At Risk
26
num Events
53
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
10
num At Risk
30
num Events
10
group Id
EG001
num Affected
12
num At Risk
26
num Events
16
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Anosmia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
4
group Id
EG001
num Affected
3
num At Risk
26
num Events
5
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
6
group Id
EG001
num Affected
6
num At Risk
26
num Events
12
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
26
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Bile duct stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
1
num At Risk
26
num Events
1
term
Blood bilirubin increased

time Frame

Date treatment consent signed to date off study, approximately 42 months and 28 days for the naïve group, and 40 months and 16 days for the refractory group.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice