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Pegfilgrastim-Cbqv

  • Biologic
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Pegfilgrastim-Cbqv does in the body

UDENYCA is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Why people take it. UDENYCA is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · 3A58010674 · read 2026-08-29

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 110 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Progression Free Survival (PFS)

The study did not show it

Who was studied
NCT03907488
How many people
994
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Progression-free survival (PFS)

The study did not show it

Who was studied
NCT04759586
How many people
244
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Failure rate

The study did not show it

Who was studied
NCT04684368
How many people
160
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)

The study did not show it

Who was studied
NCT04628767
How many people
131
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Five Year Event-free Survival (EFS)

The study did not show it

Who was studied
NCT00304070
How many people
78
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause

The study did not show it

Who was studied
NCT01256398
How many people
66
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • One injection per chemotherapy cycle instead of a daily white cell injection

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “8.5 Geriatric Use Of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over.”

    US prescribing information · 77a8576f-b91e-42ce-b613-2fa3c3d4a571 · read 2026-08-30

  • On older people, the label states: “Of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over.”

    US prescribing information · 77a8576f-b91e-42ce-b613-2fa3c3d4a571 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Although available data with UDENYCA or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products.”

    US prescribing information · 77a8576f-b91e-42ce-b613-2fa3c3d4a571 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production.”

    US prescribing information · 77a8576f-b91e-42ce-b613-2fa3c3d4a571 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1.

No source is stored against this line.

What is in the pack

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 77a8576f-b91e-42ce-b613-2fa3c3d4a571 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 77a8576f-b91e-42ce-b613-2fa3c3d4a571 · read 2026-08-29

  • UDENYCA is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS UDENYCA is a clear, colorless, preservative free solution available as: Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only., recorded as fda label in effect 2026-04-23 in the United States.

    US prescribing information · 77a8576f-b91e-42ce-b613-2fa3c3d4a571 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

Names and forms linked to this record

  • Biosimilar of

    Pegfilgrastim

    Evidence on this page does not automatically apply to this one.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Pegfilgrastim-Cbqv studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Pegfilgrastim-Cbqv are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

How many documents were read

  • 2 documents were read for this substance.

    RNAWiki source record

  • 2 of them state the same halfLife, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
3A58010674
RxNorm concept
2102703

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

  1. Withdrawn in United States, 2026, for "Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment." (openFDA drug enforcement Class I recall)

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA761039, approved 20181102 to COHERUS BIOSCIENCES INC.

    Drugs@FDA application register · BLA761039 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA761039 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (9)

On the Pegfilgrastim-Cbqv label: indicated for what?

"UDENYCA is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in…": indications and usage on Pegfilgrastim-Cbqv's label. DailyMed label · 77a8576f-b91e-42ce-b613-2fa3c3d4a571 · 2026-04-23

34 registered trials of Pegfilgrastim-Cbqv — at which phases?

Registered studies posting no result
21 of 34

34 registered studies of Pegfilgrastim-Cbqv: 17 phase2, 12 phase1, 6 phase3, 2 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

5 with a PubMed record

Show the evidence
  • phase2
    17
  • phase1
    12
  • phase3
    6
  • na or unstated
    2
  • completed
    13
  • recruiting
    9
3 more recorded rows
  • active not recruiting
    6
  • terminated
    5
  • unknown
    1

recorded 2026-09-01 · last checked 2026-09-04

Approved in 2018, withdrawn in 2026: what happened to Pegfilgrastim-Cbqv in European Union?

Approved 2018, withdrawn 2026 in European Union; the register's words: "Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment." EMA_MEDICINE_REGISTER · EMEA/H/C/004413 · 2026-09-04

1 recorded reason; European Union

Show the evidence
  • Reason
    "Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment."

recorded 2026-09-04 · last checked 2026-09-04

4 of Pegfilgrastim-Cbqv's trials stopped: accrual/recruitment, other?

accrual/recruitment (2) and other (2): Pegfilgrastim-Cbqv's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"permanently closed per sponsor's request"; 4 of 34 registered studies

Show the evidence

Trial

  • NCT02650635
    terminated; "permanently closed per sponsor's request"
  • NCT03518112
    terminated; "Due to Competing Studies"
  • NCT04156828
    terminated; "Terminated due to low accrual"
  • NCT05032183
    terminated; "The study was terminated early due to slow enrollment."

recorded 2026-09-01 · last checked 2026-09-04

Pegfilgrastim-Cbqv's half-life is 15 to 80 hours — which schedules were studied?

15 to 80 hours, the half-life Pegfilgrastim-Cbqv's label states: "The half-life of pegfilgrastim ranged from 15 to 80 hours after subcutaneous injection." DailyMed label · 77a8576f-b91e-42ce-b613-2fa3c3d4a571 · 2026-04-23

Show the evidence
  • half life pharmacokinetics
    15 to 80 hours; The half-life of pegfilgrastim ranged from 15 to 80 hours after subcutaneous injection.

recorded 2026-04-23 · last checked 2026-09-04

Which running trial of Pegfilgrastim-Cbqv could settle lifespan?

NCT04759586 measures Progression-free survival (PFS), reading out 2026-12-31.

4 open trials; n 244; "Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma"

Show the evidence

Trial

  • NCT04759586
    "Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma"; n 244; "Progression-free survival (PFS)"; 2026-12-31
  • NCT03907488
    "Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma"; n 994; "Progression Free Survival (PFS)"; 2027-03-28
  • NCT04628767
    "Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer"; n 131; "Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)"; 2027-09-30
  • NCT05535166
    "Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma"; n 130; "Progression free survival of SHH-2 infant (0-2.99 years) and young child (3-4.99 years) medulloblastoma patients treated with systemic HD-MTX-based chemotherapy only."; 2035-07

Which 5 trials of Pegfilgrastim-Cbqv posted no result?

Posted no result
5 of 5 completed trials
Registrations
NCT02385851, NCT02418104, NCT02629289, NCT02650973 and NCT01654965
Completion dates
oldest 2015-07; newest 2018-03-29
Show the evidence

Trial

  • NCT02385851
    2015-07
  • NCT02418104
    2015-12
  • NCT02629289
    2016-06
  • NCT02650973
    2016-06
  • NCT01654965
    2018-03-29

At the median, Pegfilgrastim-Cbqv's trials enrolled 48 people — anything larger?

Median enrolment
48
Largest enrolment
1381
Registered trials counted
34

Where do the label and the trials disagree about Pegfilgrastim-Cbqv?

"Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment." against "approved": withdrawal status vs register status for Pegfilgrastim-Cbqv.

EMA_MEDICINE_REGISTER, Drugs@FDA; 1 recorded pair

Show the evidence
  • EMA_MEDICINE_REGISTER EMEA/H/C/004413
    Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.; 2026-09-04
  • Drugs@FDA BLA761039
    approved; 2026-08-28
Where it is registered

Where it’s registered

Withdrawn in United States, 2026, for "Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment." (openFDA drug enforcement Class I recall)

Identifiers, relations and other names

The exact record

CAS number
208265-92-3
RxCUI
2102703

Relations

Trade name
Udenyca, ARMLUPEG, Cegfila, ENNUMO, FULPHILA, FYLNETRA
Also called
B-12019, B12019, Cegfila [EMA EPAR], GRANULOCYTE COLONY-STIMULATING FACTOR PEGFILGRASTIM, GRANULOCYTE COLONY-STIMULATING FACTOR PEGFILGRASTIM [MI]
Development code
CHS-1701, HSP-130
Sources (5)

Sources

ClinicalTrials.gov — US Government work · EMA medicine register · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 3 required field(s) not terminal: Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 5 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.