TriangleNCT03345784 · OUTCOME
Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- events
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
To determine the acute and late toxicity of AZD1775 when administered to patients with gynecological cancer in combination with standard radiotherapy and concurrent cisplatin. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a subanalysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to one or both study treatments.
Groups in this outcome
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 1, 3, and 5, and receive 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.
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 3 and 5, and receive 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.
| Group | Source count |
|---|---|
| Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 4 |
| Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 5 |
Reported measurements
All Grade 1-2 Toxicities
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 46 | Not reported | Not reported | Not reported | Not reported |
| Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 53 | Not reported | Not reported | Not reported | Not reported |
Related Grade 1-2 Toxicities
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 37 | Not reported | Not reported | Not reported | Not reported |
| Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 36 | Not reported | Not reported | Not reported | Not reported |
All Grade 3-4 Toxicities
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 8 | Not reported | Not reported | Not reported | Not reported |
| Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 3 | Not reported | Not reported | Not reported | Not reported |
Related Grade 3-4 Toxicities
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 8 | Not reported | Not reported | Not reported | Not reported |
| Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 53
- title
- All Grade 1-2 Toxicities
- categories
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 36
- title
- Related Grade 1-2 Toxicities
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 3
- title
- All Grade 3-4 Toxicities
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 3
- title
- Related Grade 3-4 Toxicities
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- To determine the acute and late toxicity of AZD1775 when administered to patients with gynecological cancer in combination with standard radiotherapy and concurrent cisplatin. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a subanalysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to one or both study treatments.
- groups
- description
- Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 1, 3, and 5, and receive 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
- OG000
- title
- Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
- description
- Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 3 and 5, and receive 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
- OG001
- title
- Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Frequency and Severity of AZD1775 Toxicity Events in Patients With Gynecological Cancer in Combination With Standard RT and Concurrent Cisplatin
- type
- SECONDARY
- unit Of Measure
- events
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Preserved source evidence · Not medical advice