Analysis of the Clinical Experience With Rucaparib in the... | NCT04539327

Status Module

Name	Class
Clovis Oncology, Inc.	INDUSTRY

Description Module

Name	Type	Description	Arm Group Labels	Other Names
Rucaparib	Drug	Participating local sites (GEICO-associated hospitals with expertise in gynecological cancer management) will enter clinical data of those patients who have previously participated in the rucaparib access program (RAP) in Spain and have given their consent.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Relevant Co-morbidities	Patient characteristics and medical history Detected diseases include: arterial hypertension, diabetes melliutus, COPD, ischemic cardiomyopathy, cerebrovascular disease, obesity, etc. Measurements were done at baseline	0 months - Measurements were done at baseline
Other Previous Cancers?	Patient characteristics and medical history. Descriptive statistics: Other cancers present during trial including endometrial, breast , colorrectal, lung or other cancers Measurements were done at baseline	0 months - Measurements were done at baseline
Family History of Cancers?	Patient characteristics and medical history Family history of other cancers including ovarian, breast and others Measurements were done at baseline	0 months - Measurements were done at baseline
FIGO STAGE	Stage = tumor size and location; higher stage = more spread metastasis I Tumor confined to the corpus uteri IA No or less than half myometrial invasion IB Invasion equal to or more than half of the myometrium IC IA+IB + ascites IC1 surgical spill IC2 Capsule rupture before surgery or tumor on ovarian surface II Tumor invades cervical stroma, but does not extend beyond the uterus III Local and/or regional spread of the tumor IIIA Tumor invades the serosa of the corpus uteri and/or adnexae IIIA2 involvement of uterine subserosa or spread through uterine serosa IIIB Vaginal involvement and/or parametrial involvement IIIC Metastases to pelvic and/or para-aortic lymph nodes IIIC1 Positive pelvic nodes IIIC2 Positive para-aortic nodes with or without positive pelvic lymph nodes IV Tumor invades bladder and/or bowel mucosa, and/or distant metastases IVA Tumor invasion of bladder and/or bowel mucosa IVB Distant metastasis (intra-abdominal metastases and/or inguinal nodes)	0 months - Measurements were done at baseline

Eligibility Module

Name	Affiliation	Role
Alfonso Yubero, Dr.	Hospital Clínico Universitario Lozano Blesa	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Torrecárdenas		Almería	Andalusia	04009	Spain
Hospital Universitario Virgen de la Victoria

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 29, 2021

Arm/Group Information

ID	Title	Description
BG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
BG001	Rucaparib Maintenance	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

age of the participant

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00015 OG00112

Primary

Other Previous Cancers?

Patient characteristics and medical history. Descriptive statistics: Other cancers present during trial including endometrial, breast , colorrectal, lung or other cancers Measurements were done at baseline

Posted

Count of Participants

Participants

0 months - Measurements were done at baseline

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."
OG001

Primary

Family History of Cancers?

Patient characteristics and medical history Family history of other cancers including ovarian, breast and others Measurements were done at baseline

Posted

Count of Participants

Participants

0 months - Measurements were done at baseline

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."
OG001	Rucaparib - Maintenance

Primary

FIGO STAGE

Stage = tumor size and location; higher stage = more spread metastasis I Tumor confined to the corpus uteri IA No or less than half myometrial invasion IB Invasion equal to or more than half of the myometrium IC IA+IB + ascites IC1 surgical spill IC2 Capsule rupture before surgery or tumor on ovarian surface II Tumor invades cervical stroma, but does not extend beyond the uterus III Local and/or regional spread of the tumor IIIA Tumor invades the serosa of the corpus uteri and/or adnexae IIIA2 involvement of uterine subserosa or spread through uterine serosa IIIB Vaginal involvement and/or parametrial involvement IIIC Metastases to pelvic and/or para-aortic lymph nodes IIIC1 Positive pelvic nodes IIIC2 Positive para-aortic nodes with or without positive pelvic lymph nodes IV Tumor invades bladder and/or bowel mucosa, and/or distant metastases IVA Tumor invasion of bladder and/or bowel mucosa IVB Distant metastasis (intra-abdominal metastases and/or inguinal nodes)

Posted

Count of Participants

Participants

0 months - Measurements were done at baseline

ID	Title	Description
OG000	Rucaparib - Maintenance	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"

Primary

Tumor Histology

Patient characteristics and medical history Tumor histology history Measurements were done at baseline

Posted

Count of Participants

Participants

0 months - Measurements were done at baseline

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."
OG001	Rucaparib - Maintenance

Primary

BCRA Status

Patient characteristics and medical history mutational status (BRCA 1/2 [germline/somatic] and in other HRR genes) Measurements were done at baseline

Posted

Count of Participants

Participants

0 months - Measurements were done at baseline

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."
OG001	Rucaparib - Maintenance

Primary

Deficiencies in Other Genes Involved in Homologous Recombination

Patient characteristics and medical history Other HRR deficiencies including RAD51C, RAD51D, PALBB2, BRIP1, CHEK1, CHEK2, BARD1, FAM175A, NEN, ATM, EMSY and others Measurements were done at baseline

Posted

Count of Participants

Participants

0 months - Measurements were done at baseline

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."
OG001

Primary

Surgeries Before Rucaparib

Patient characteristics and medical history Total number of surgeries per patient before treatment started Measurements were done at baseline

Posted

Count of Participants

Participants

0 months - Measurements were done at baseline

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."
OG001	Rucaparib - Maintenance

Primary

Previous Lines

Patient characteristics and medical history:

Prior lines of platinum-based chemotherapy

Posted

Mean

Standard Deviation

Treatment lines

0-24 months

ID	Title	Description
OG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
OG001	Rucaparib - Maintenance	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response

Primary

PARPi Before Rucaparib

Patient characteristics and medical history:

PARPi treatment before rucaparib Measurements were done at baseline

Posted

Count of Participants

Participants

0 months - Measurements were done at baseline

ID	Title	Description
OG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
OG001	Rucaparib - Maintenance

Primary

Average Dose of Rucaparib Received Per 12 Hours

Rucaparib dosing data Descrption: average dose of rucaparib administered (mg/12h)

Posted

Mean

Standard Deviation

mg/12h

0-12 months

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."
OG001	Rucaparib - Maintenance

Primary

Rucaparib Drug Exposure

Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching).

Rucaparib drug exposure in months Patient 14-001 has been eliminated for not following the treatment scheme

Posted

Count of Participants

Participants

0-24 months

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."

Primary

Dose Reductions

Specific description: How many dose reductions had to be conducted on each patient

*Patient 14-001 from treatment group has been eliminated by not following the tratment scheme

Posted

Count of Participants

Participants

0-12 months

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."

Primary

Number of Dose Interruptions

Specific description: How many dose interruptions had to be conducted on each patient

*Patient 14-001 from treatment group has been eliminated by not following the tratment scheme

Posted

Count of Participants

Participants

0-12 months

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."

Primary

Duration of Response (DoR)

Rucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution).

For maintenance patients: Duration of response has been calculated taking into account the date of CR or RP prior to RAP until progression (on last follow date) during Rucaparib as a maintenance treatment.

For treatment patients: Duration of response has been calculated taking into account the best response date (PR or CR) during Rucaparib until progression of follow-up date (Only patients with PR or CR as best overall response)

Posted

Mean

Standard Deviation

months

0-36 months

ID	Title	Description
OG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.

Primary

End of Treatment

Description: Rucaparib exposure termination (reasons)

Posted

Count of Participants

Participants

0-24 months

ID	Title	Description
OG000	Rucaparib - Treatment	"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant."

Primary

Objective Response Rate (ORR)

Rucaparib efficacy data ORR: Confirmed best overall tumor response of CR or PR according to RECIST v1.1 or Response and normalization or Response according to Rustin criteria. The RECIST v1.1 answer prevailed over the Rustin criterion answer except where RECIST is 'Not assessable' and Rustin criterion is different than 'Not assessable'.

ORR was calculated only on the treatment population and not on the maintenance population.

*This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".

Posted

Count of Participants

Participants

0-24 months

ID	Title	Description
OG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.

Primary

Progression-free Survival (PFS)

It represents the length of time during and after treatment that a patient lives with the disease, but without it getting worse.

Posted

Median

95% Confidence Interval

months

0-24 months

ID	Title	Description
OG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.

Primary

Radiological Best Overall Response

Rucaparib efficacy data Radiological best overall response - Only 19 radiologically evaluable patients (treatment group only)

Posted

Count of Participants

Participants

0-24 months

ID	Title	Description
OG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.

Primary

Biological Best Overall Response

Biological best overall response - Only 16 assessable patients (Treatment arm only)

Posted

Count of Participants

Participants

0-24 months

ID	Title	Description
OG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rucaparib - Treatment	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.	24	33	0	33	28	33
EG001	Rucaparib - Maintenance	The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain. Studied patients were the ones recruited between July 2020 and February 2021 Inclusion criteria: Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. Adult women (18 years or more at the time of diagnosis). Exclusion criteria: 1. Patients without medical record available (lost, empty or unretrievable clinical information). Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response	8	18	0	18	16	18

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment		EG00018 events13 affected33 at risk EG0015 events2 affected18 at risk
GGT increased	Hepatobiliary disorders	Systematic Assessment	gamma-glutamyl transferase (GGT) increased	EG0000 events0 affected33 at risk EG0011 events1 affected18 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	Neutrophil count decreased	EG0004 events3 affected33 at risk EG0013 events2 affected18 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	Platelet count decreased	EG00012 events10 affected33 at risk EG0011 events1 affected18 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment		EG0002 events2 affected33 at risk EG0013 events2 affected18 at risk
ALT increased	Hepatobiliary disorders	Systematic Assessment	Alanine transaminase (ALT) increased	EG0007 events4 affected33 at risk EG0016 events5 affected18 at risk
ALP increased	Renal and urinary disorders	Systematic Assessment	Alkaline Phosphatase (ALP)increased	EG0004 events3 affected33 at risk EG0012 events2 affected18 at risk
AST increased	Hepatobiliary disorders	Systematic Assessment	Aspartate aminotransferase (AST) increased	EG0005 events4 affected33 at risk EG0017 events5 affected18 at risk
Asthenia	General disorders	Systematic Assessment		EG0003 events3 affected33 at risk EG0011 events1 affected18 at risk
Colonic obstruction	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected33 at risk EG0010 events0 affected18 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment		EG0002 events2 affected33 at risk EG0011 events1 affected18 at risk
Creatinine increased	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected33 at risk EG0016 events4 affected18 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected33 at risk EG0015 events4 affected18 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment		EG0001 events1 affected33 at risk EG0013 events2 affected18 at risk
Fatigue	General disorders	Systematic Assessment		EG0007 events7 affected33 at risk EG0016 events5 affected18 at risk
Hyponatremia	Endocrine disorders	Systematic Assessment		EG0007 events1 affected33 at risk EG0010 events0 affected18 at risk
Intestinal obstruction	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected33 at risk EG0010 events0 affected18 at risk
Myelodysplastic syndrome	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected33 at risk EG0010 events0 affected18 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment		EG0005 events5 affected33 at risk EG0018 events7 affected18 at risk
Pleural efussion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected33 at risk EG0010 events0 affected18 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected33 at risk EG0013 events1 affected18 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment		EG0003 events3 affected33 at risk EG0012 events2 affected18 at risk

"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.

Studied patients were the ones recruited between July 2020 and February 2021

Inclusion criteria:

Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
Adult women (18 years or more at the time of diagnosis).

Exclusion criteria:

1. Patients without medical record available (lost, empty or unretrievable clinical information).

Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment

This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"

The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.

Studied patients were the ones recruited between July 2020 and February 2021

Inclusion criteria:

Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
Adult women (18 years or more at the time of diagnosis).

Exclusion criteria:

1. Patients without medical record available (lost, empty or unretrievable clinical information).

Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment

This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response

T"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.

Studied patients were the ones recruited between July 2020 and February 2021

Inclusion criteria:

Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
Adult women (18 years or more at the time of diagnosis).

Exclusion criteria:

1. Patients without medical record available (lost, empty or unretrievable clinical information).

Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment

This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"

ID	Term
D000077216	Carcinoma, Ovarian Epithelial
D005185	Fallopian Tube Neoplasms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D010051	Ovarian Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases