untitled h1
e. expedited reporting for investigational

Expedited reporting is required if the patient has received at least one dose of the investigational agent(s) as part of the trial. Reporting requirements are provided in Table 16.1. The investigational agent used in this study is rucaparib.  
If there is any question about the reportability of an adverse event or if Internet connectivity is please telephone or email the SAE Program Manager at the Operations Office, 210-614-8808 or adr@swog.org, before preparing the report.  
NOTE: For this study, all adverse events requiring expedited reporting must initially be reported on the Adverse Event Form in the appropriated Treatment Cycle folder in Medidata Rave. Once the adverse event is entered into RAVE, the Rules Engine will confirm whether or not the adverse event requires expedited reporting. The CTEP-AERS report must then be initiated directly from the Adverse Event Form in Medidata Rave. Do not initiate the CTEP-AERS report via the CTEP-AERS website. Sites are encouraged to confirm the Expedited Reporting Evaluation Recommendation with the reporting criteria outlined in Table 16.1.  
Table 16.1:  
Late Phase 2 and Phase 3 Studies: Expedited Reporting Requirements for Adverse Events that Occur on Studies under a Non-CTEP IND within 30 Days of the Last Administration of the Investigational Agent/Intervention rucaparib  
FDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312)  
NOTE: Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, whether or not they are considered related to the investigational agent(s)/intervention (21 CFR 312.64)  
An adverse event is considered serious if it results in ANY of the following outcomes:  
1) Death 2) A life-threatening adverse event 3) An adverse event that results in inpatient hospitalization or prolongation of existing hospitalization for ≥ 24 hours 4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5) A congenital anomaly/birth defect.  
6) Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6).  
| Hospitalization               | Grade 1          | Timeframes       | Grade 3 Timeframes   | Grade 4 & 5   |
|-------------------------------|------------------|------------------|----------------------|---------------|
| Grade 2                       |                  |                  |                      |               |
| Timeframes                    | Timeframes       |                  |                      |               |
| Resulting in  Hospitalization | 10 Calendar Days |                  |                      |               |
| ≥ 24 hrs                      | 24-Hour 5        |                  |                      |               |
| Not resulting in              | Calendar Days    |                  |                      |               |
| Hospitalization               | Not required     | 10 Calendar Days |                      |               |
| ≥ 24 hrs                      |                  |                  |                      |               |  
NOTE: Protocol specific exceptions to expedited reporting of serious adverse events are found in the Specific Protocol Exceptions to Expedited Reporting (SPEER) portion of the CAEPR or Section 16.1f.  
Expedited AE reporting timelines are defined as:  
o "24-Hour; 5 Calendar Days" - The AE must initially be reported via CTEP-AERS within 24 hours of learning of the AE, followed by a complete expedited report within 5 calendar days of the initial 24hour report.  
o "10 Calendar Days" - A complete expedited report on the AE must be submitted within 10 calendar days of learning of the AE.  
Serious adverse events that occur more than 30 days after the last administration of investigational agent/intervention and have an attribution of possible, probable, or definite require reporting as follows:  
Expedited 24-hour notification followed by complete report within 5 calendar days for:  
- All Grade 4, and Grade 5 AEs Expedited 10 calendar day reports for:  
- Grade 2 adverse events resulting in hospitalization or prolongation of hospitalization  
- Grade 3 adverse events May 5, 2011  
Page 58 Version Date 12/14/20 f. Additional Instructions or Exceptions to CTEP-AERS Expedited Reporting
untitled h1
1. group-specific instructions.

Supporting Documentation Submission - Within 5 calendar days submit documentation supporting the CTEP-AERS report to the SWOG  
Operations Office by fax 210-614-0006. Specific instructions will be sent by email to the reporting site by the SAE Program Manager.  
2. The adverse events listed below also require expedited reporting via CTEP-AERS for this trial:  
- All second and secondary malignancies (See Section 16.1g)  
- Any grade of pneumonitis is reportable:  
o pneumonitis o interstitial lung disease o pulmonary fibrosis o acute interstitial pneumonitis o alveolitis necrotizing o alveolitis o hypersensitivity pneumonitis o organizing pneumonia g. Reporting Secondary Malignancy, including AML/ALL/MDS  
1. A secondary malignancy is a cancer caused by treatment for a previous malignancy (e.g., treatment with investigational agent/intervention, radiation or chemotherapy). A secondary malignancy is not considered a metastasis of the initial neoplasm.  
SWOG requires all secondary malignancies that occur following treatment with an agent under a Non-NCI IND to be reported via CTEP-AERS. Three options are available to describe the event.  
- Leukemia secondary to oncology chemotherapy (e.g., Acute Myelocytic Leukemia [AML])  
- Myelodysplastic syndrome (MDS)  
- Treatment-related secondary malignancy Any malignancy possibly related to cancer treatment (including AML/MDS)  
should also be reported via the routine reporting mechanisms outlined in each protocol.  
A second malignancy is one unrelated to the treatment of a prior malignancy (and is NOT a metastasis from the initial malignancy). For this protocol, second malignancies also require expedited reporting via CTEPAERS.  
For more information see:  
  
Page 59 Version Date 12/14/20 http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/  
aeguidelines.pdf 2. Supporting documentation should be submitted to CTEP in accordance with instructions provided by the CTEP-AERS system. Supporting documentation must also be submitted to SWOG Operations Office by fax to 210-614-0006.  
NOTE: If a patient has been enrolled in more than one NCI-sponsored study, the report must be submitted for the most recent trial.
untitled h1
h. reporting serious adverse events

SWOG Operations will forward reports of all serious adverse events and events of overdose (defined as any dose above the protocol-specified dose of rucaparib)  
associated with an SAE within 24 hours of NCI/CTEP receipt of serious adverse event documentation from the study site.
untitled h1
i. reporting pregnancy pregnancy loss

1. Pregnancy Study participants who become pregnant while on study; that pregnancy should be reported in an expedited manner via CTEP-AERS  
as Grade 3 "Pregnancy, puerperium and perinatal conditions - Other  
(pregnancy)" under the Pregnancy, puerperium and perinatal conditions SOC.  
Additionally, the pregnancy outcome for patients on study should be reported via CTEP-AERS at the time the outcome becomes known, accompanied by the same Pregnancy Report Form used for the initial  
report.  
2. Pregnancy Loss Pregnancy loss is defined in CTCAE as "Death in utero." Pregnancy loss should be reported expeditiously as Grade 4  
"Pregnancy loss" under the Pregnancy, puerperium and perinatal conditions SOC.  
A Pregnancy loss should NOT be reported as a Grade 5 event under the  
  
Pregnancy, puerperium and perinatal conditions SOC, as currently CTEPAERS recognizes this event as a patient death.  
3. Death Neonatal Death neonatal is defined in CTCAE as "Newborn death occurring during the first 28 days after birth A neonatal death should be reported expeditiously as Grade 4 "Death neonatal" under the General disorders and administration SOC.  
Neonatal death should NOT be reported as a Grade 5 event under the General disorders and administration SOC as currently CTEP-AERS  
recognizes this event as a patient death.  
  
NOTE: When submitting CTEP-AERS reports for "Pregnancy, "Pregnancy loss",  
or "Neonatal loss", the Pregnancy Information Form should also be completed and faxed with any additional medical information to 210-614-0006. The potential risk of exposure of the fetus to the investigational agent(s) or chemotherapy agent(s)  
should be documented in the "Description of Event" section of the CTEP-AERS  
report.  
The Pregnancy Information Form is available at:  
http://ctep.cancer.gov/protocolDevelopment/adverse_effects.htm.  
1 Curtin, N.J., Inhibiting the DNA damage response as a therapeutic manoeuvre in cancer. Br J  
Pharmacol 169(8): p. 1745-65, 2013.  
2 Broustas, C.G., Lieberman, H. B., DNA Damage Response Genes and the Development of Cancer Metastasis. Radiat Res. 181 (2): 111-130, 2014. PMCID: PMC4064942 3 Swisher, E.M., et al., Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma  
(ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol 18(1): p. 7587, 2017.  
4 Mateo, J., et al., DNA repair defects and olaparib in metastatic prostate cancer. NEJM, 2015.  
5 Shroff, R., et al., Rucaparib monotherapy in patients with pancreatic cancer and a known deleterious BRCA mutation. JCO-Precision Oncology, 2018.  
6 Owonikoko, T.K., et al., A systematic analysis of efficacy of second-line chemotherapy in sensitive and refractory small-cell lung cancer. J Thorac Oncol 7(5): p. 866-72, 2012.  
7 Fung-Kee-Fung, M., et al., Optimal chemotherapy treatment for women with recurrent ovarian cancer. Curr Oncol 14(5): p. 195-208, 2007.  
8 Giaccone, G., et al., Teniposide in the treatment of small-cell lung cancer: the influence of prior chemotherapy. J Clin Oncol 6(8): p. 1264-70, 1988.  
9 Ledermann, J., et al., Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol 15(8): p. 852-61, 2014.  
10 Fong, P.C., et al., Poly(ADP)-ribose polymerase inhibition: frequent durable responses in BRCA  
carrier ovarian cancer correlating with platinum-free interval. J Clin Oncol 28(15): p. 2512-9, 2010.  
11 Mazzoni, F., et al., From clinical trials to clinical practice: predictors of response to erlotinib in advanced non-small cell lung cancer patients pretreated with chemotherapy. Tumori 97(2): p. 1605, 2011.  
12 Swisher, E.M., et al., Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma  
(ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol 18(1): p. 7587, 2017.  
13 Mazzoni, F., et al., From clinical trials to clinical practice: predictors of response to erlotinib in advanced non-small cell lung cancer patients pretreated with chemotherapy. Tumori 97(2): p. 1605, 2011.  
14 Coleman, R.L., et al., Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 390(10106): p. 1949-1961, 2017.  
15 Plummer, R., et al., Phase 1 dose-escalation study of the PARP inhibitor CEP-9722 as monotherapy or in combination with temozolomide in patients with solid tumors. Cancer Chemother Pharmacol 74(2): p. 257-65, 2014.  
  
Page 62 Version Date 12/14/20  
16 Plummer, R., et al., A phase II study of the potent PARP inhibitor, Rucaparib (PF-01367338, AG014699), with temozolomide in patients with metastatic melanoma demonstrating evidence of chemopotentiation. Cancer Chemother Pharmacol 71(5): p. 1191-9, 2013.  
17 Wilson, R.H., et al., A phase I study of intravenous and oral rucaparib in combination with chemotherapy in patients with advanced solid tumours. Br J Cancer 116(7): p. 884-892, 2017.  
18 Kristeleit, R., et al., A Phase I-II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors. Clin Cancer Res 23(15):  
p. 4095-4106, 2017.  
19 Swisher, E.M., et al., Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma  
(ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol 18(1): p. 7587, 2017.  
20 Coleman, R.L., et al., Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 390(10106): p. 1949-1961, 2017.  
21 Oza AM, Tinker AV, Oaknin A, Shapira-Frommer R, McNeish IA, Swisher EM, et al. Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10 and ARIEL2. Gynecol Oncol, 2017.  
22 Coleman, R.L., et al., Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 390(10106): p. 1949-1961, 2017.  
23 Oza AM, Tinker AV, Oaknin A, Shapira-Frommer R, McNeish IA, Swisher EM, et al. Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10  
and ARIEL2. Gynecol Oncol, 2017.  
24 Coleman, R.L., et al., Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 390(10106): p. 1949-1961, 2017.  
25 Oza AM, Tinker AV, Oaknin A, Shapira-Frommer R, McNeish IA, Swisher EM, et al. Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10 and ARIEL2. Gynecol Oncol, 2017.  
26 Fulcher N, Shenolikar RA, Durden E, Moore KN, editors. Incidence of secondary myelodysplastic syndrome and acute myeloid leukemia in patients with ovarian and breast cancer in real-world setting in the U.S. 2017 ASCO Annual Meeting: J Clin Oncol 35 (suppl; abstr 5574), 2017.  
27 Friedenson B. The BRCA1/2 pathway prevents hematologic cancers in addition to breast and ovarian cancers. BMC Cancer 7:152, 2007.  
28 Eisenhauer, E., Therasse, P., Bogaerts, J., Schwartz, L., Sargent, D., Ford, R., … Verweij, J.  
(2009). New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1).  
European Journal of Cancer, 45(2), 228–247. doi: 10.1016/j.ejca.2008.10.026  
  
18.5 Examples of Cytochrome (CYP) Substrates 18.6 Intake Calendar - Rucaparib 18.7 Patient Drug Information Handout and Wallet Card  
  
|       | Need for                                                                                                | Physical Ability   |                     |                   |
|-------|---------------------------------------------------------------------------------------------------------|--------------------|---------------------|-------------------|
| Class | Cardiac Symptoms                                                                                        | Limitations        | Additional Rest*    | To Work**         |
| I     | None                                                                                                    | None               | None                | Full Time         |
| II    | Only moderate                                                                                           | Slight             | Usually only slight | Usually full time |
|       | or occasional                                                                                           |                    |                     |                   |
| III   | Defined, with less                                                                                      | Marked             | Usually moderate    | Usually part time |
|       | than ordinary                                                                                           |                    |                     |                   |
|       | activity                                                                                                |                    |                     |                   |
| IV    | May be present                                                                                          | Extreme            | Marked              | Unable to work    |
|       | even at rest, & any                                                                                     |                    |                     |                   |
|       | activity increases                                                                                      |                    |                     |                   |
|       | discomfort                                                                                              |                    |                     |                   |
| *     | To control or relieve symptoms, as determined by the patient, rather than as advised by  the physician. |                    |                     |                   |
| **    | At accustomed occupation or usual tasks.                                                                |                    |                     |                   |  
  
  
18.2 Monitoring Plan For information on the LUNGMAP Monitoring Plan, please refer to LUNGMAP Appendix 18.2.  
Frozen Plasma and Buffy Coat The SWOG Biospecimen Bank will receive frozen plasma and buffy coat at up to 5 time points per patient. Upon receipt, the Bank will accession, barcode, and Bank specimens in a -80°C freezer.  
Formalin-fixed Paraffin-Embedded (FFPE) Tissue The SWOG Biospecimen Bank will receive FFPE specimens as either blocks or slides/sections at up to 1 timepoint per patient. Upon receipt, the Bank will accession, barcode, and Bank specimens at ambient temperature.  
At the end of the study, the Bank will receive notification from the SWOG Statistics and Data Management Center to distribute specimens for testing.  
  
For information on rucaparib storage temperature excursion, please refer to S1900A  
Section 3.1 and submit this form to Clovis within 24 hours after becoming aware of excursion and prior to dosing.  
  
Page 68 Version Date 12/14/20  
| Investigator Initiated Trial Information  IIT Number: Investigator: Site Number, if  applicable: Site Country:  Study Staff Name: Title:  Email: Tel:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Report Date:                                |       |       |       |        |       |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-------|-------|-------|--------|-------|
| Investigational Product Incident Summary  IP Name: Active IP Dosage Form and Strength:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | Placebo Dosage Form and Strength:           |       |       |       |        |       |
| rucaparib tablets                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 200mg                                       | 250mg | 300mg | 200mg | 250mg | 300mg |
| Lot No(s): (i.e H02288A1)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | IP Type: (ex: bottle, blister, vial) Bottle |       |       |       |        |       |
| Select type of incident: temperature excursion, lost IP, damaged IP, miscount, or other. Complete one form for each incident.   Lost IP / Damaged Shipment (Shipment # if applicable:_________________) Damaged IP   Miscount   over-filled  under-filled Other:_____________________________  Patient ID: Visit Cycle # Patient's Current Dose: Frequency:  Patient Next Visit Date (DD-MMM-YYYY):  Date Patient Reported incident to the Site (DD-MMM-YYYY):  Please indicate number of IP tablets/bottles/etc. that were affected:  Did patient miss any doses?  If yes, please ensure the patient recorded the missed dose in their patient diary, if applicable.  Yes  No  Do you need urgent resupply due to this event?  Yes  No  Did you attach accompanying documents and/or photos?  Yes  No   Temperature Excursion  Please complete below table for summary of excursion and explanation of event. Check appropriate boxes.  Excursion  Date  (DD-MMM-YYYY)  Minimum  Excursion  Temperature  Was the IP previously involved in  another temperature excursion?  If yes, please provide date.   C  F C  Yes  No Yes  No (DD-MMM-YYYY)  Maximum  Excursion  Temperature  Excursion  Duration  (hours)  Temperature  Log  Attached?  Comments: |                                             |       |       |       |        |       |  
Page 69 Version Date 12/14/20 Signature: ______________________________________________________ Date: __________________  
Email this form to RucaSupply@clovisoncology.com (preferred)  
or Fax to + 1 415 276 5777  
THIS SECTION IS TO BE COMPLETED BY CLOVIS PERSONNEL ONLY  
Clovis Comment:  
Clovis Review Name & Title:  
Clovis Signature: _________________________________________________ Date: ___________________  
  
  
Page 70 Version Date 12/14/20 18.5 Examples of Cytochrome (CYP) Substrates
untitled h1
see section 7.2 for precautions.

Because lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list for the most up-to-date listing of agents; medical reference texts such as the Physicians' Desk Reference may also provide this information.  
Please consult the "Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers," which can be found on the U.S. Food and Drug Administration website at See the following FDA links for additional examples of sensitive substrates.  
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugI  
nteractionsLabeling/ucm093664.htm  
Page 71 Version Date 12/14/20 18.6 Intake Calendar - Rucaparib SWOG Study: S1900A  
Site Personnel Instructions  
- Patient number should be recorded on the bottle label in the spaces provided by site personnel at the time of assignment to patient.  
- Ensure that patient clearly understands the guidelines for self-medication.  
- Patient should be given enough supply to last until their next study visit.  
- Unused drug and/or empty bottles should be returned to the site at the next study visit.  
- A new Intake Calendar must be given to a patient with a change in dose or tablet strength. Re-educate the patient regarding their dose schedule as stated below.  
- It is recommended that sites contact the patient/caregiver by telephone to confirm  
  
dosage adherence in the first few days of Cycle 1 and during the first cycle following any tablet strength change.  
Please review the following with the patient:  
- Cycle, Start Date and Start Time information with the patient. If possible, have the patient document their first dose in the appropriate calendar box.  
- Patient's dose schedule: Rucaparib should be taken twice a day, as close to the same time each day as possible. Provide patient with the instructions on how to document this schedule appropriately.  
Include on the Intake Calendar and review with the patient: dosage, strength of tablets provided, quantity to take at each dose, and tablet description (i.e.  
blue, round tablet).  
Verify that the tablet strength listed on the bottle label matches the instructions provided to the patient.  
Tell the patient what the tablets will look like based on the strength provided:  
o 200 mg tablets: blue, round shaped tablets, marked with "C2" o 250 mg tablets: white, diamond shaped tablets, marked with "C25" o 300 mg tablets: yellow, oval shaped tablets, marked with "C3"  
- Rucaparib can be taken with or without food.  
- How to document vomited, missed, or skipped doses in the specific areas provided.  
Cycle: __________ Start Date: __________ Start Day (circle one): Sun M Tu W Th F Sat Instructions for the patient:  
This is a 21-day cycle calendar on which you are to record the number of rucaparib tablets you take each day. You should:  
- Take rucaparib 2 times a day at the same time of day as close to 12 hours apart as possible, unless otherwise instructed.  
- Take rucaparib with at least 8 oz. (240 mL) of room temperature water with or without food.  
- Put the date in the box on the calendar and note the time of both doses for each day.  
- Check off if the dose was taken or not  
- Swallow the tablet whole; do not chew them prior to swallowing.  
- Document any changes to taking the doses in the comments section provided below If you miss a dose, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose.  
If you vomit a dose, do not take an extra dose. Take your next dose at your usual scheduled time.  
If you take too much of rucaparib, call your site personnel listed below.  
If you develop any side effects, mark this on the calendar on the day you note the effect. Contact site personnel listed below.  
- Take medication as directed by study doctor.  
Storage:  
Store rucaparib tablets should be stored at room temperature (between 15 ºC and 30ºC) in their original container. Keep the medication in their bottles: do not transfer to any other container or share your medication with anyone. Keep out of the reach of children and pets.  
Your dose is: ________________________ (example: 600mg twice daily)  
You should take: ______ (number of pills) _________ mg (example: 300 mg, 200 mg or 250 mg).  
Description of tablet: ______________________ (i.e. blue, round tablet)  
  
If you have questions, contact: _________________________ Telephone: ______________________  
Special Instructions:  
| Special Instructions:  Date Was dose taken?   | What time?                                         | # tablets taken (tablet  strength)                       | Comments   |
|-----------------------------------------------|----------------------------------------------------|----------------------------------------------------------|------------|
| st dose:                                      | 8 : 00 am/pm   8 : 00 am/pm  st dose: 2 (300 mg) . |                                                          |            |
|  Yes                                         | □ No                                               |                                                          |            |
| nd dose:                                      | 2nd dose: 2 (300 mg) .                             |                                                          |            |
|  Yes                                         | □ No                                               |                                                          |            |
| Day1                                          |                                                    |                                                          |            |
| Example                                       | st dose:                                           | ____:____am/pm   ____:____am/pm   1st dose: ____________ |            |
| □ Yes                                         | □ No                                               |                                                          |            |
| nd dose:                                      | 2nd dose:____________                              |                                                          |            |
| □ Yes                                         | □ No                                               |                                                          |            |
| ____/____/____                                |                                                    |                                                          |            |  
| S1900A  Page 73                |                                                    |                        |                                    |          |
|--------------------------------|----------------------------------------------------|------------------------|------------------------------------|----------|
| Version Date 12/14/20          |                                                    |                        |                                    |          |
| Date                           | Was dose taken?                                    | What time?             | # tablets taken (tablet  strength) | Comments |
| st dose:                       | 8 : 00 am/pm   8 : 00 am/pm  st dose: 2 (300 mg) . |                        |                                    |          |
|  Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose: 2 (300 mg) .                             |                        |                                    |          |
|  Yes                          | □ No                                               |                        |                                    |          |
| Day2                           |                                                    |                        |                                    |          |
| Example                        | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| Day 3                          |                                                    |                        |                                    |          |
| ____/____/____                 | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| Day 4                          |                                                    |                        |                                    |          |
| ____/____/____  st dose:       | 1st dose: ____________                             |                        |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| Day 5                          |                                                    |                        |                                    |          |
| ____/____/____  st dose:       | 1st dose: ____________                             |                        |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| Day 6                          |                                                    |                        |                                    |          |
| ____/____/____                 | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| Day 7                          |                                                    |                        |                                    |          |
| ____/____/____                 | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| Day 8                          |                                                    |                        |                                    |          |
| ____/____/____                 | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| Day 9                          |                                                    |                        |                                    |          |
| ____/____/____                 | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| Day 10                         |                                                    |                        |                                    |          |
| ____/____/____                 | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| Day 11                         |                                                    |                        |                                    |          |
| ____/____/____                 | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| nd dose:                       | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                          | □ No                                               |                        |                                    |          |
| ____/____/____                 |                                                    |                        |                                    |          | | S1900A  Page 74                 |                                                    |                        |                                    |          |
|---------------------------------|----------------------------------------------------|------------------------|------------------------------------|----------|
| Version Date 12/14/20           |                                                    |                        |                                    |          |
| Date                            | Was dose taken?                                    | What time?             | # tablets taken (tablet  strength) | Comments |
| st dose:                        | 8 : 00 am/pm   8 : 00 am/pm  st dose: 2 (300 mg) . |                        |                                    |          |
|  Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose: 2 (300 mg) .                             |                        |                                    |          |
|  Yes                           | □ No                                               |                        |                                    |          |
| Day 12  Example                 | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm  |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| Day 13                          |                                                    |                        |                                    |          |
| ____/____/____                  | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm  |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| Day 14                          |                                                    |                        |                                    |          |
| ____/____/____  st dose:        | 1st dose: ____________                             |                        |                                    |          |
| ____:____am/pm  ____:____am/pm  |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| Day 15                          |                                                    |                        |                                    |          |
| ____/____/____  st dose:        | 1st dose: ____________                             |                        |                                    |          |
| ____:____am/pm   ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| Day 16                          |                                                    |                        |                                    |          |
| ____/____/____  st dose:        | 1st dose: ____________                             |                        |                                    |          |
| ____:____am/pm  ____:____am/pm  |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| Day 17                          |                                                    |                        |                                    |          |
| ____/____/____  st dose:        | 1st dose: ____________                             |                        |                                    |          |
| ____:____am/pm   ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| Day 18                          |                                                    |                        |                                    |          |
| ____/____/____                  | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm  |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| Day 19                          |                                                    |                        |                                    |          |
| ____/____/____                  | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm  |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| Day 20                          |                                                    |                        |                                    |          |
| ____/____/____                  | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm   ____:____am/pm |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| Day 21                          |                                                    |                        |                                    |          |
| ____/____/____                  | st dose:                                           | 1st dose: ____________ |                                    |          |
| ____:____am/pm  ____:____am/pm  |                                                    |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| nd dose:                        | 2nd dose:____________                              |                        |                                    |          |
| □ Yes                           | □ No                                               |                        |                                    |          |
| ____/____/____                  |                                                    |                        |                                    |          |  
  
18.7 PATIENT DRUG INFORMATION HANDOUT AND WALLET CARD
untitled h1
information for patients their caregivers

Interactions with Other Drugs and Herbal Supplements The patient ____________________________ is enrolled on a clinical trial using the experimental study drug, Rucaparib. This clinical trial is sponsored by SWOG. This form is addressed to the patient but includes important information for others who care for this patient.  
These are the things that you as a healthcare provider need to know:  
Rucaparib interacts with certain specific enzymes in your liver, certain transport proteins that help move drugs in and out of cells. These enzymes and transport proteins may interact with over-the-counter, herbal, and prescriptions medications.  
- The enzymes in question are CYP1A2, CYP2C9, CYP2C19, and CYP3A. Rucaparib blocks drugs that need these enzymes to break down further in the liver. Co-administration of rucaparib with drugs that are CYP1A2, CYP2C9, CYP2C19, and CYP3A substrates may increase risks of toxicities of these drugs.  
- Rucaparib also inhibits the function of MATE1, MATE2-K, and OCT1, which are proteins that move drugs in and out of cells/organ. Co-administration of rucaparib with drugs that are substrates of these transport proteins may increase risks of toxicities of these drugs.  
To the patient: Take this paper with you to your medical appointments and keep the attached information card in your wallet.  
Rucaparib may interact with other drugs which can cause side effects. For this reason, it is very important to tell your study doctors of any medicines you are taking before you enroll onto this clinical trial. It is also very important to tell your doctors if you stop taking any regular medicines, or if you start taking a new medicine while you take part in this study. When you talk about your current medications with your doctors, include medicine you buy without a prescription (over-the-counter remedy), or any herbal supplements such as St. John's Wort. It is helpful to bring your medication bottles or an updated medication list with you.  
Many health care providers can write prescriptions. You must tell all your health care providers (doctors, physician assistants, nurse practitioners, pharmacists) you are taking part in a clinical trial.
untitled h1
these are the things that

Rucaparib must be used very carefully with other medicines that use certain liver enzymes or transport proteins to be effective or to be cleared from your system. Before you enroll onto the clinical trial, your study doctor will work with your regular health care providers to review any medicines and herbal supplements that are considered "strong inducers/inhibitors or substrates" of CYP450, transport proteins MATE1, MATE2-K, and OCT1. These characteristics may change how rucaparib or other medicine works in your body.  
- Please be very careful! Over-the-counter drugs (including herbal supplements) may contain ingredients that could interact with your study drug. Speak to your doctors or pharmacist to determine if there could be any side effects.  
  
Page 76 Version Date 12/14/20 o Prescription drugs such as metformin (for diabetes), digoxin (for heart conditions), or drugs with narrow therapeutic window like warfarin (or Coumadin, for blood clots).  
_____________________________________.  
 - Your regular health care provider should check a frequently updated medical reference or call your study doctor before prescribing any new medicine or discontinuing any medicine. Your study doctor's name is  
_____________________________________ and he or she can be contacted at  
  
STUDY DRUG INFORMATION WALLET CARD  
You are enrolled on a clinical trial using the experimental study drug rucaparib. This clinical trial is sponsored by the NCI. Rucaparib may interact with drugs that are processed by your liver, or use certain transport proteins in your body. Because of this, it is very important to:  
Tell your doctors if you stop taking any medicines or if you start taking any new medicines.  
Tell all your health care providers (doctors, physician assistants, nurse practitioners, or pharmacists) that you are taking part in a clinical trial.  
Check with your doctor or pharmacist whenever you need to use an over-the-counter medicine or herbal supplement.  
Rucaparib interacts with specific liver enzymes called CYP1A2, CYP2C9/19, and CYP3A, transport proteins (MATE1/2-K, and OCT1) and must be used very carefully with medicines that require these enzymes and transport proteins.  
Before prescribing new medicines, your regular health care providers should go to a frequently-updated medical reference for a list of drugs to avoid, or contact your study doctor.  
Your study doctor's name is _____________________________  
and can be contacted at _________________________________.