## Protocol Section
### Identification Module
**NCT ID:** NCT04460079

**Brief Title:** Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN

**Official Title:** Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients

#### Organization Study ID Info
**ID:** PEGAGEN.CIN.AJ.95 (IV)
#### Organization
**Class:** INDUSTRY
**Full Name:** Cinnagen
### Status Module
#### Completion Date
**Date:** 2019-09-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-07-07

**Type:** ACTUAL

**Last Update Submit Date:** 2020-07-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-09-07

**Type:** ACTUAL

#### Start Date
**Date:** 2016-03-29

**Type:** ACTUAL

**Status Verified Date:** 2020-05

#### Study First Post Date
**Date:** 2020-07-07
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-27
**Study First Submit QC Date:** 2020-07-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Cinnagen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran.

The primary objective of this study was safety assessment, including the rate of AEs. The secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced FN.

**Detailed Description:** The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran.

Data was gathered in two booklets, each containing information on four cycles of chemotherapy, which was filled by the designated physician. The duration of PegaGen® treatment was at the physicians' discretion based on the patient's condition.

The primary objective of this study was safety assessment, including the rate of AEs. The secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced FN.

This study was single arm and 654 subjects participated across various tumor types and regimens.

### Conditions Module

**Conditions:**

- Chemotherapy-induced Neutropenia

**Keywords:**

- Febrile neutropenia

- Pegfilgrastim

- Post-marketing surveillance

- Chemotherapy-induced neutropenia

- myelosuppressive chemotherapy

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 654

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy

**Name:** Peg-filgrastim

**Other Names:**

- PegaGen®

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Safety evaluation was reported using summary statistics. For each AE, data was summarized using incidence according to system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done and its results was reported by frequency and percentage.

**Measure:** Safety assessment, using incidence according to SOC and PT of AEs and SAEs

**Time Frame:** This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.

#### Secondary Outcomes

**Description:** The frequency of neutropenia and neutropenic fever was reported

**Measure:** Effectiveness assessment: The frequency of neutropenia and neutropenic fever

**Time Frame:** This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients aged ≥18 years,
* with the diagnosis of various types of cancers (such as lymphoma, breast, lung, testicular, prostate, ovary and gastrointestinal cancers), receiving first-line chemotherapy regimens with a high FN risk, which PegaGen® is injected due to physician decision.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients receiving various tumor types and regimens with chemotherapy regimens of high FN risk, will be included.

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Oncology & Hematology Dep., Booali Hosp., Islamic Azad University, Tehran, Iran

**Name:** Arash Jenabian, Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Jenabian A, Ehsanpour A, Mortazavizadeh SMR, Raafat J, Razavi M, Khosravi A, Seifi S, Salimi B, Anjidani N, Kafi H. Evaluating the safety and effectiveness of PegaGen(R) (pegfilgrastim) for the prevention of chemotherapy-induced febrile neutropenia: a post-marketing surveillance study. Support Care Cancer. 2022 Oct;30(10):8151-8158. doi: 10.1007/s00520-022-07265-2. Epub 2022 Jul 6.

**PMID:** 35792924

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000000380

- Term: Agranulocytosis

- ID: D000007970

- Term: Leukopenia

- ID: D000095542

- Term: Cytopenia

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000007960

- Term: Leukocyte Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12443

- Name: Neutropenia

- Relevance: HIGH

- As Found: Neutropenia

- ID: M2454

- Name: Hyperthermia

- Relevance: LOW

- As Found: Unknown

- ID: M8464

- Name: Fever

- Relevance: LOW

- As Found: Unknown

- ID: M30221

- Name: Febrile Neutropenia

- Relevance: HIGH

- As Found: Febrile Neutropenia

- ID: M30220

- Name: Chemotherapy-Induced Febrile Neutropenia

- Relevance: LOW

- As Found: Unknown

- ID: M3730

- Name: Agranulocytosis

- Relevance: LOW

- As Found: Unknown

- ID: M10973

- Name: Leukopenia

- Relevance: LOW

- As Found: Unknown

- ID: M3170

- Name: Cytopenia

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10963

- Name: Leukocyte Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2606

- Name: Granulocytopenia

- Relevance: HIGH

- As Found: Neutropenia

### Condition Browse Module - Meshes

- ID: D000009503

- Term: Neutropenia

- ID: D000064147

- Term: Febrile Neutropenia

### Intervention Browse Module - Ancestors

- ID: D000000276

- Term: Adjuvants, Immunologic

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1945

- Name: Lenograstim

- Relevance: HIGH

- As Found: 30 minutes

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000078224

- Term: Lenograstim

### Misc Info Module

- Version Holder: 2024-05-24
