NCT01736917 · OUTCOME
Self-Reported Assessment of Nausea
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors · Source last updated 2016-05-25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- millimeters
- Interval / dispersion
- Full Range
- Time frame
- Days 1-8 of chemotherapy regimen
What was measured
the patient's self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS) median.
The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. Median VAS scores (in mm) are reported, per day.
Analysis population: 54 patients completed the VAS on all 8 days and were eligible for analysis.
Groups in this outcome
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
\- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
* Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
* Dexamethasone 20mg PO (orally) daily, D1 and 2
* Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
* Fosaprepitant 150mg IV on D5
* Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
* No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | 54 |
|---|
Reported measurements
median VAS score - day 1
Values in millimeters · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | 0 | Not reported | 0 | 24 | Not reported |
|---|
median VAS score - day 2
Values in millimeters · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | 0 | Not reported | 0 | 76 | Not reported |
|---|
median VAS score - day 3
Values in millimeters · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | 4.5 | Not reported | 0 | 60 | Not reported |
|---|
median VAS score - day 4
Values in millimeters · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | 18.5 | Not reported | 0 | 95 | Not reported |
|---|
median VAS score - day 5
Values in millimeters · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | 23.5 | Not reported | 0 | 92 | Not reported |
|---|
median VAS score - day 6
Values in millimeters · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | 12.5 | Not reported | 0 | 80 | Not reported |
|---|
median VAS score - day 7
Values in millimeters · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | 7 | Not reported | 0 | 90 | Not reported |
|---|
median VAS score - day 8
Values in millimeters · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone | 3 | Not reported | 0 | 84 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 24
- value
- 0
- title
- median VAS score - day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 76
- value
- 0
- title
- median VAS score - day 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 60
- value
- 4.5
- title
- median VAS score - day 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 95
- value
- 18.5
- title
- median VAS score - day 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 92
- value
- 23.5
- title
- median VAS score - day 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 80
- value
- 12.5
- title
- median VAS score - day 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 90
- value
- 7
- title
- median VAS score - day 7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 84
- value
- 3
- title
- median VAS score - day 8
- description
- the patient's self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS) median.
The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. Median VAS scores (in mm) are reported, per day.
- dispersion Type
- Full Range
- groups
- description
- Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
\- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
* Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
* Dexamethasone 20mg PO (orally) daily, D1 and 2
* Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
* Fosaprepitant 150mg IV on D5
* Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
* No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl
- id
- OG000
- title
- Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
- param Type
- MEDIAN
- population Description
- 54 patients completed the VAS on all 8 days and were eligible for analysis.
- reporting Status
- POSTED
- time Frame
- Days 1-8 of chemotherapy regimen
- title
- Self-Reported Assessment of Nausea
- type
- SECONDARY
- unit Of Measure
- millimeters
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