NCT04439227 · ADVERSE EVENTS
Adverse events
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
- Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
- Other-event reporting threshold
- 5%
All 33 treated patients were included in the all-cause mortality analysis and in the toxicity analysis.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Treatment (Adavosertib) | 18 / 33 | 26 / 33 | 27 / 33 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Death NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 33
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 33
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Gastrointestinal disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Urinary tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Infections and infestations - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Fall
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 33
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 33
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 33
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Flu like symptoms
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 33
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- term
- Bloating
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 33
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 33
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Flatulence
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 33
- term
- Nausea
Complete source fields
- description
- All 33 treated patients were included in the all-cause mortality analysis and in the toxicity analysis.
- event Groups
- deaths Num Affected
- 27
- deaths Num At Risk
- 33
- description
- Patients receive adavosertib 300 mg PO QD on days 1-5 and 8-12 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- EG000
- other Num Affected
- 26
- other Num At Risk
- 33
- serious Num Affected
- 18
- serious Num At Risk
- 33
- title
- Treatment (Adavosertib)
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 33
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 33
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 33
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Flu like symptoms
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 33
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- term
- Bloating
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 33
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 33
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Flatulence
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 33
- term
- Nausea
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Death NOS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Edema limbs
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 33
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 33
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 33
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 33
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Gastrointestinal disorders - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Urinary tract infection
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Infections and infestations - Other, specify
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Injury, poisoning and procedural complications
- source Vocabulary
- CTCAE 4.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 33
- term
- Fall
- time Frame
- Assessed every 21 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration.
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