NCT02872103 · OUTCOME
Number of Participants With Use of Antibiotics and Pain Medications
Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy · Source last updated 2021-05-05
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 4 chemotherapy cycles, about 12 weeks
What was measured
Antibiotics and pain medications use will be recorded for each chemotherapy cycle and overall cycles
Analysis population: 3 subjects terminated early
Groups in this outcome
F-627
F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
Placebo
Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
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 |
|---|
| F-627 | 83 |
|---|
| Placebo | 39 |
|---|
Reported measurements
Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| F-627 | 83 |
|---|
| Placebo | 39 |
|---|
antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
no antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 74 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 2
Analysis denominator · Participants
| Group | Source count |
|---|
| F-627 | 83 |
|---|
| Placebo | 38 |
|---|
antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
no antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 80 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| F-627 | 82 |
|---|
| Placebo | 37 |
|---|
antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
no antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 80 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| F-627 | 82 |
|---|
| Placebo | 37 |
|---|
antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
no antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 81 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
All cycles
Analysis denominator · Participants
| Group | Source count |
|---|
| F-627 | 83 |
|---|
| Placebo | 39 |
|---|
antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
no antibiotic and pain medications use
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| F-627 | 70 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 13
- title
- antibiotic and pain medications use
- measurements
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 26
- title
- no antibiotic and pain medications use
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 39
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- antibiotic and pain medications use
- measurements
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 36
- title
- no antibiotic and pain medications use
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 38
- units
- Participants
- title
- Cycle 2
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- antibiotic and pain medications use
- measurements
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 36
- title
- no antibiotic and pain medications use
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Cycle 3
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- antibiotic and pain medications use
- measurements
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 37
- title
- no antibiotic and pain medications use
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Cycle 4
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 15
- title
- antibiotic and pain medications use
- measurements
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 24
- title
- no antibiotic and pain medications use
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 39
- units
- Participants
- title
- All cycles
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- Antibiotics and pain medications use will be recorded for each chemotherapy cycle and overall cycles
- groups
- description
- F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
- id
- OG000
- title
- F-627
- description
- Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 3 subjects terminated early
- reporting Status
- POSTED
- time Frame
- 4 chemotherapy cycles, about 12 weeks
- title
- Number of Participants With Use of Antibiotics and Pain Medications
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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