NCT03345784 · ADVERSE EVENTS

Adverse events

Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers · Source last updated 2024-02-20

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 years
Other-event reporting threshold: 0%

Through regular investigator assessment, regular laboratory testing, etc. Frequency and severity of adverse events were tabulated using counts and proportions.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 Patients undergo external beam radiation therapy (45-50Gy) on days 1-5, receive 100mg AZD1775 PO on days 1, 3, and 5, and receive 40 mg/m2 cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.	1 / 4	4 / 4	0 / 4
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 Patients undergo external beam radiation therapy (45-50Gy) on days 1-5, receive 100mg AZD1775 PO on days 3 and 5, and receive 40 mg/m2 cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.	1 / 5	5 / 5	0 / 5

Group identifiers: EG000: Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 · EG001: Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -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
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Grade 3 Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Grade 3 Lymphocyte Count Decreased

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 v5.0
stats
group Id
EG000
num Affected
4
num At Risk
4
num Events
5
group Id
EG001
num Affected
5
num At Risk
5
num Events
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
6
group Id
EG001
num Affected
4
num At Risk
5
num Events
4
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
3
num At Risk
5
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Hypomagnesemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Platelet count decreased
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
6
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
6
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
3
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
3
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Neutrophil count decreased
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
5
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Lymphocyte count decreased
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
2
num At Risk
5
num Events
3
term
Lymphopenia

Complete source fields

description

Through regular investigator assessment, regular laboratory testing, etc. Frequency and severity of adverse events were tabulated using counts and proportions.

event Groups

deaths Num Affected
0
deaths Num At Risk
4
description
Patients undergo external beam radiation therapy (45-50Gy) on days 1-5, receive 100mg AZD1775 PO on days 1, 3, and 5, and receive 40 mg/m2 cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
id
EG000
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
deaths Num Affected
0
deaths Num At Risk
5
description
Patients undergo external beam radiation therapy (45-50Gy) on days 1-5, receive 100mg AZD1775 PO on days 3 and 5, and receive 40 mg/m2 cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
id
EG001
other Num Affected
5
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
4
num At Risk
4
num Events
5
group Id
EG001
num Affected
5
num At Risk
5
num Events
7
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
6
group Id
EG001
num Affected
4
num At Risk
5
num Events
4
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
3
num At Risk
5
num Events
4
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Hypomagnesemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Platelet count decreased
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
6
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
6
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
3
num At Risk
4
num Events
3
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
3
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
2
num At Risk
4
num Events
3
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Hyponatremia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Neutrophil count decreased
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
1
num At Risk
5
num Events
2
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Lymphocyte count decreased
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
2
num At Risk
5
num Events
3
term
Lymphopenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
2
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
term
Grade 3 Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
term
Grade 3 Lymphocyte Count Decreased

time Frame

2 years

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

Preserved source evidence · Not medical advice